PART 868—ANESTHESIOLOGY DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 47 FR 31142, July 16, 1982, unless otherwise noted. Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 868.1 Scope. (a) This part sets forth the classification of anesthesiology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, an anesthesiology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. [52 FR 17734, May 11, 1987, as amended at 67 FR 76681, Dec. 13, 2002; 78 FR 18233, Mar. 26, 2013] § 868.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17734, May 11, 1987] § 868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2313, Jan. 14, 2000] Subpart B—Diagnostic Devices § 868.1030 Manual algesimeter. (a) Identification. (b) Classification. [54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025] § 868.1040 Powered algesimeter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] § 868.1075 Argon gas analyzer. (a) Identification. (b) Classification. § 868.1100 Arterial blood sampling kit. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] § 868.1120 Indwelling blood oxyhemoglobin concentration analyzer. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 FR 22577, June 12, 1987; 69 FR 34920, June 23, 2004] § 868.1150 Indwelling blood carbon dioxide partial pressure (P 2CO2 (a) Identification. CO2 CO2 CO2 (b) Classification. [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] § 868.1200 Indwelling blood oxygen partial pressure (P O2 (a) Identification. O2 O2 O2 (b) Classification. [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] § 868.1400 Carbon dioxide gas analyzer. (a) Identification. (b) Classification. § 868.1430 Carbon monoxide gas analyzer. (a) Identification. (b) Classification. § 868.1500 Enflurane gas analyzer. (a) Identification. (b) Classification. § 868.1505 Ventilatory electrical impedance tomograph. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing; (ii) Real time evaluation of local impedance variation; (iii) Plethysmogram accuracy testing; and (iv) Use life testing of reusable components. (3) Performance data must validate reprocessing instructions for any reusable components of the device. (4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Guidance for interpretation of the images generated; (ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device; (iii) A use life for any reusable components; and (iv) Instructions for reprocessing any reusable components. [84 FR 15098, Apr. 15, 2019] § 868.1575 Gas collection vessel. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] § 868.1620 Halothane gas analyzer. (a) Identification. (b) Classification. § 868.1640 Helium gas analyzer. (a) Identification. (b) Classification. § 868.1670 Neon gas analyzer. (a) Identification. (b) Classification. § 868.1690 Nitrogen gas analyzer. (a) Identification. (b) Classification. § 868.1700 Nitrous oxide gas analyzer. (a) Identification. (b) Classification. § 868.1720 Oxygen gas analyzer. (a) Identification. (b) Classification. § 868.1730 Oxygen uptake computer. (a) Identification. (b) Classification. § 868.1750 Pressure plethysmograph. (a) Identification. (b) Classification. § 868.1760 Volume plethysmograph. (a) Identification. (b) Classification. § 868.1780 Inspiratory airway pressure meter. (a) Identification. (b) Classification. § 868.1800 Rhinoanemometer. (a) Identification. (b) Classification. § 868.1840 Diagnostic spirometer. (a) Identification. (b) Classification. § 868.1850 Monitoring spirometer. (a) Identification. (b) Classification. § 868.1860 Peak-flow meter for spirometry. (a) Identification. (b) Classification. § 868.1870 Gas volume calibrator. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] § 868.1880 Pulmonary-function data calculator. (a) Identification. (b) Classification. § 868.1890 Predictive pulmonary-function value calculator. (a) Identification. (b) Classification. § 868.1900 Diagnostic pulmonary-function interpretation calculator. (a) Identification. (b) Classification. § 868.1910 Esophageal stethoscope. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 868.1920 Esophageal stethoscope with electrical conductors. (a) Identification. (b) Classification. § 868.1930 Stethoscope head. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001] § 868.1965 Switching valve (ploss). (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025] § 868.1975 Water vapor analyzer. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] § 868.1980 Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia. (a) Identification. (b) Classification. (1) Clinical performance testing under anticipated conditions of use must evaluate the location accuracy of anatomical landmarks identified by the device. (2) Human factors testing must demonstrate that the user can correctly use the device to identify anatomical structures, based solely on reading the instructions for use. (3) Software verification, validation, and hazard analysis must be performed, including demonstrated compatibility with ultrasound devices labeled to be compatible with the device. (4) Labeling must include: (i) The recommended training for safe use of the device; (ii) Pertinent details of the clinical data collected to evaluate the performance of the device; and (iii) A warning against over-reliance on device output. [91 FR 32340, June 1, 2026] Subpart C—Monitoring Devices § 868.2025 Ultrasonic air embolism monitor. (a) Identification. (b) Classification. § 868.2200 Adjunctive pain measurement device for anesthesiology. (a) Identification. (b) Classification. (1) Clinical data must be provided to validate the algorithm in support of the intended use and include the following: (i) Comparison of output measure(s) to a reference method to demonstrate the required accuracy and/or sensitivity and specificity of the output measure(s); (ii) Demonstration of the consistency of the output and representativeness of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment; (iii) Evaluation of the type of pain ( e.g., (iv) For devices using algorithms based on machine learning, the clinical validation must be completed using a dataset that is separate from the training dataset. (2) Software description, verification, and validation based on comprehensive hazard analysis must be performed. Software documentation must include: (i) Full characterization of technical parameters of the software, including any algorithm(s); (ii) Description of mechanisms for handling of noisy or missing data and poor signal quality under expected conditions of use; (iii) Specification of acceptable incoming sensor data quality control measures; (iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on output accuracy; and (v) Justification for the validity of the algorithm(s) ( e.g., (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing under anticipated conditions of use must demonstrate the ability of the device software/algorithm to detect adequate input signal quality and handle noisy or missing data and poor signal quality. (4) Usability assessment must be provided to mitigate the risk of misinterpretation of device output. (5) The patient contacting components of the device must be demonstrated to be biocompatible. (6) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of any hardware components of the device. (7) Labeling must include the following: (i) A summary of the clinical validation data, including demographics and other relevant characteristics of the clinical study participants (including age, sex, race or ethnicity, and patient condition), the anesthetic regimen (including types ( e.g., (ii) A description of what the device measures and outputs to the user. (iii) The type of sensor data used, including specification of compatible sensors for data acquisition. (iv) Warnings identifying sensor signal-acquisition factors that may impact output. (v) Warnings to identify and avoid specific patient conditions or concomitant medical therapies that could mask pain or negatively impact device performance leading to inaccurate measurements. (8) Recommendations for clinical interpretation of the output, including warning(s) emphasizing the adjunctive use of the output measure(s). [91 FR 32342, June 1, 2026] § 868.2250 Monitor for opioid induced impairment of oxygenation. (a) Identification. (b) Classification. (1) Clinical performance data under anticipated conditions of use must demonstrate that the device performs as intended and include the following: (i) Comparison to a clinically relevant reference method to demonstrate and support the accuracy and level of sensitivity and specificity for detection of opioid induced impairment of oxygenation; (ii) Demonstration of the consistency of the output and representativeness of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment; (iii) Performance reported in clinically significant and distinct subpopulations and intended use environments; (iv) For devices using algorithms based on machine learning, the clinical validation must be completed using a dataset that is separate from the training dataset; and (v) Simulated use testing of hardware and sensors to characterize accuracy and precision across the intended use population. (2) Software description, verification, and validation based on comprehensive hazard analysis must be performed. Software documentation must include: (i) Full characterization of technical parameters of the software, including any algorithm(s); (ii) Specification of acceptable incoming sensor data quality control measures; and (iii) Justification for the validity of the algorithm(s) ( e.g., (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Performance testing of sensor hardware to characterize sensor accuracy and precision; and (ii) Compatibility testing of sensors with other hardware and software components of the device. (4) Usability assessment must be provided to demonstrate that intended device users can safely and correctly use the device. (5) All components of the device that contact the skin must be demonstrated to be biocompatible. (6) Performance testing must demonstrate the electromagnetic compatibility, wireless coexistence, electrical safety, thermal safety, and mechanical safety of any hardware components and sensors of the device. (7) Labeling must include the following: (i) A summary of the clinical validation data, including relevant characteristics of the included subpopulations and use environments in the clinical study, and performance metrics, including sensitivity, specificity, positive predictive value, and negative predictive value for each of the subpopulations, use environments, and opioid types; (ii) Principles of sensor operation, including warnings for how to avoid interfering with sensor readings; (iii) Information for preventing an overdose, recognizing signs of an overdose, and treating an overdose; (iv) Warnings identifying that the device is not designed to differentiate between the target condition ( e.g., e.g., (v) Warnings against overreliance on the device; and (vi) A warning regarding the need for supervised use with awareness of effective countermeasures ( e.g., [91 FR 39461, June 30, 2026] § 868.2300 Bourdon gauge flowmeter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2320 Uncompensated thorpe tube flowmeter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2340 Compensated thorpe tube flowmeter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2350 Gas calibration flowmeter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2375 Breathing frequency monitor. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002] § 868.2376 Device for sleep apnea testing based on mandibular movement. (a) Identification. (b) Classification. (1) Clinical data must be provided. This assessment must fulfill the following: (i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment. (iii) The assessment must compare device performance with a clinical comparator device ( e.g., (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) The performance data must be provided to demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (4) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include: (i) A full characterization of the software technical parameters, including algorithms; (ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications; and (iii) A description of all mitigations for failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy. (5) Labeling must include: (i) A description of what the device measures and outputs to the user; (ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics ( e.g., (iii) Guidance for interpretation of the measurements, including a statement that the device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor; and (iv) The expected performance of the device for all intended use populations and environments. [91 FR 21383, Apr. 22, 2026] § 868.2377 Apnea monitor. (a) Identification. (b) Classification. [67 FR 46852, July 17, 2002] § 868.2380 Nitric oxide analyzer. (a) Identification. (b) Classification. [65 FR 14465, Mar. 3, 2000] § 868.2385 Nitrogen dioxide analyzer. (a) Identification. (b) Classification. [65 FR 11465, Mar. 3, 2000, as amended at 84 FR 71811, Dec. 30, 2019] § 868.2450 Lung water monitor. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 65 FR 19834, Apr. 13, 2000] § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor. (a) Identification. (b) Classification. [54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002] § 868.2500 Cutaneous oxygen (PcO2) monitor. (a) Identification. (b) Classification. [67 FR 76681, Dec. 13, 2002, as amended at 84 FR 71811, Dec. 30, 2019] § 868.2550 Pneumotachometer. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] § 868.2600 Airway pressure monitor. (a) Identification. (b) Classification. § 868.2610 Gas pressure gauge. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2620 Gas pressure calibrator. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2700 Pressure regulator. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2775 Electrical peripheral nerve stimulator. (a) Identification. (b) Classification. § 868.2875 Differential pressure transducer. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2885 Gas flow transducer. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.2900 Gas pressure transducer. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] Subparts D-E [Reserved] Subpart F—Therapeutic Devices § 868.5090 Emergency airway needle. (a) Identification. (b) Classification. § 868.5095 Retrograde intubation device. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Wire guide tensile, flex, fracture, and corrosion testing; (ii) Catheter tensile strength testing at likely points of failure; (iii) Catheter kink radius testing; (iv) Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids; (v) Dimensional validation; (vi) Accuracy testing of markings; and (vii) Validation of the maximum airway pressure. (2) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (3) The device must be demonstrated to be biocompatible. (4) Labeling must include: (i) Instructions for use; and (ii) Package labels that clearly identify the minimum compatible size of endotracheal tube. [86 FR 73678, Dec. 28, 2021] § 868.5100 Nasopharyngeal airway. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5105 External negative pressure airway aid. (a) Identification. (b) Classification. (1) Clinical performance testing must document any adverse events observed during clinical use, including impaired blood flow, and demonstrate that the device performs as intended under anticipated conditions. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated patient positions, does not fail during use, and does not lose negative pressure capability. The following testing should be performed: (i) Ability of the device to maintain a seal during various patient positions; (ii) Device leakage testing to demonstrate the device maintains vacuum; (iii) Drop testing to ensure the device does not incur functional damage after dropping the device; and (iv) Functional testing after high and low storage temperature. (3) All patient contacting components must be demonstrated to be biocompatible. (4) Labeling must include: (i) A summary of clinical testing results, including any adverse events and evidence that effectiveness has been achieved. (ii) Technical specifications of the device, including collar sizes, maximum duration of use, operating temperature, and storage temperature range. (iii) Technical specifications of the vacuum source, including maximum vacuum level and operational vacuum level. (iv) Instructions for use that includes how to place the device, determination of size, verification of suction, reference to training materials, and information on troubleshooting the device if it does not attach properly. (v) A warning to screen patients for carotid artery disease due to the probable risk of the device to dislodge arterial plaques in the carotid artery. (vi) A warning to exclude patients with anatomical abnormalities. (vii) A warning not to use the device during medical procedures involving medications that contain propofol. [82 FR 60867, Dec. 26, 2017] § 868.5110 Oropharyngeal airway. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5115 Device to relieve acute upper airway obstruction. (a) Identification. (b) Classification. [65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000] § 868.5120 Anesthesia conduction catheter. (a) Identification. (b) Classification. § 868.5130 Anesthesia conduction filter. (a) Identification. (b) Classification. § 868.5140 Anesthesia conduction kit. (a) Identification. (b) Classification. § 868.5150 Anesthesia conduction needle. (a) Identification. (b) Classification. § 868.5160 Gas machine for anesthesia or analgesia. (a) Gas machine for anesthesia Identification. (2) Classification. (b) Gas machine for analgesia Identification. (2) Classification. § 868.5165 Nitric oxide administration apparatus. (a) Identification. (b) Classification. [65 FR 11465, Mar. 3, 2000] § 868.5170 Laryngotracheal topical anesthesia applicator. (a) Identification. (b) Classification. § 868.5180 Rocking bed. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] § 868.5220 Blow bottle. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 868.5240 Anesthesia breathing circuit. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5250 Breathing circuit circulator. (a) Identification. (b) Classification. § 868.5260 Breathing circuit bacterial filter. (a) Identification. (b) Classification. § 868.5270 Breathing system heater. (a) Identification. (b) Classification. § 868.5273 Positive airway pressure delivery system. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes. (ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device. (iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use. (iv) Carbon dioxide rebreathing testing must be performed. (v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed. (vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures. (vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed. (viii) Maximum output temperature testing of delivered gas, if humidified, must be performed. (3) Performance data must validate reprocessing instructions for any reusable components of the device. (4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Therapy pressure range; (ii) Use life and replacement schedule for all components; (iii) Cleaning instructions; and (iv) Instructions for assembly and connection of device components. [83 FR 52966, Oct. 19, 2018] § 868.5280 Breathing tube support. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001] § 868.5300 Carbon dioxide absorbent. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5310 Carbon dioxide absorber. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5320 Reservoir bag. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5330 Breathing gas mixer. (a) Identification. (b) Classification. § 868.5340 Nasal oxygen cannula. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001] § 868.5350 Nasal oxygen catheter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001] § 868.5365 Posture chair for cardiac or pulmonary treatment. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001] § 868.5375 Heat and moisture condenser (artificial nose). (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5400 Electroanesthesia apparatus. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 61 FR 50706, Sept. 27, 1996] § 868.5420 Ether hook. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001;90 FR 55983, Dec. 4, 2025 ] § 868.5430 Gas-scavenging apparatus. (a) Identification. (b) Classification. § 868.5440 Portable oxygen generator. (a) Identification. (b) Classification. § 868.5450 Respiratory gas humidifier. (a) Identification. (b) Classification. § 868.5454 High flow humidified oxygen delivery device. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following: (i) Alarm testing must be performed; (ii) Continuous use thermal stability testing must be performed; (iii) Humidity output testing must be performed; and (iv) Blender performance testing must evaluate fraction of inspired oxygen ( Fi 2 (3) Performance data must validate cleaning instructions for any reusable components of the device. (4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include: (i) A description of available Fi 2 (ii) Instructions for applicable flowrates for all intended populations; (iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry; (iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and (v) A description of all alarms and their functions. [83 FR 54007, Oct. 26, 2018] § 868.5460 Therapeutic humidifier for home use. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5470 Hyperbaric chamber. (a) Identification. (b) Classification. § 868.5480 Isocapnic ventilation device. (a) Identification. (b) Classification. (1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics: (i) Gas concentration accuracy testing for the range of intended concentrations; (ii) Airway pressure delivery accuracy testing; (iii) Supplemental O 2 (iv) Alarm testing; and (v) Use life testing. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Labeling must include the following: (i) Instructions for use; (ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and (iii) Use life specification. [86 FR 68397, Dec. 2, 2021] § 868.5530 Flexible laryngoscope. (a) Identification. (b) Classification. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5540 Rigid laryngoscope. (a) Identification. (b) Classification. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5550 Anesthetic gas mask. (a) Identification. (b) Classification. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5560 Gas mask head strap. (a) Identification. (b) Classification. [47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001] § 868.5570 Nonrebreathing mask. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5580 Oxygen mask. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5590 Scavenging mask. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5600 Venturi mask. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5620 Breathing mouthpiece. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 868.5630 Nebulizer. (a) Identification. (b) Classification. § 868.5640 Medicinal nonventilatory nebulizer (atomizer). (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 868.5650 Esophageal obturator. (a) Identification. (b) Classification. § 868.5655 Portable liquid oxygen unit. (a) Identification. (b) Classification. § 868.5665 Powered percussor. (a) Identification. (b) Classification. § 868.5675 Rebreathing device. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 868.5690 Incentive spirometer. (a) Identification. (b) Classification. § 868.5700 Nonpowered oxygen tent. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 868.5710 Electrically powered oxygen tent. (a) Identification. (b) Classification. § 868.5720 Bronchial tube. (a) Identification. (b) Classification. § 868.5730 Tracheal tube. (a) Identification. (b) Classification. § 868.5740 Tracheal/bronchial differential ventilation tube. (a) Identification. (b) Classification. § 868.5750 Inflatable tracheal tube cuff. (a) Identification. (b) Classification. § 868.5760 Cuff spreader. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 868.5770 Tracheal tube fixation device. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5780 Tube introduction forceps. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5790 Tracheal tube stylet. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5795 Tracheal tube cleaning brush. (a) Identification. (b) Classification. [51 FR 40388, Nov. 6, 1986, as amended at 66 FR 38795, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986] § 868.5810 Airway connector. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5820 Dental protector. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5830 Autotransfusion apparatus. (a) Identification. (b) Classification. § 868.5860 Pressure tubing and accessories. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 868.5870 Nonrebreathing valve. (a) Identification. (b) Classification. § 868.5880 Anesthetic vaporizer. (a) Identification. (b) Classification. § 868.5895 Continuous ventilator. (a) Identification. (b) Classification. § 868.5905 Noncontinuous ventilator (IPPB). (a) Identification. (b) Classification. § 868.5915 Manual emergency ventilator. (a) Identification. (b) Classification. § 868.5925 Powered emergency ventilator. (a) Identification. (b) Classification. § 868.5935 External negative pressure ventilator. (a) Identification. (b) Classification. § 868.5955 Intermittent mandatory ventilation attachment. (a) Identification. (b) Classification. § 868.5965 Positive end expiratory pressure breathing attachment. (a) Identification. (b) Classification. § 868.5975 Ventilator tubing. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 868.5995 Tee drain (water trap). (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, 2001] Subpart G—Miscellaneous § 868.6100 Anesthetic cabinet, table, or tray. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38796, July 25, 2001] § 868.6175 Cardiopulmonary emergency cart. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38796, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 868.6225 Nose clip. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38796, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 868.6250 Portable air compressor. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] § 868.6400 Calibration gas. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 868.6700 Anesthesia stool. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 54 FR 25049, June 12, 1989; 66 FR 38796, July 25, 2001] § 868.6810 Tracheobronchial suction catheter. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 65 FR 2314, Jan. 14, 2000] § 868.6820 Patient position support. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 868.6885 Medical gas yoke assembly. (a) Identification. (b) Classification. [47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]