Revolutionfull Face Mask

• • Ongoing Z-1780-2022 FDA Class I ·initiated 6 Sep 2022

  No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

510(k) Number

K082866 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Respironics Inc., Sleep & Home Respiratory Group →

• What types of respiratory therapy is the Revolution Full Face Mask designed to support, and where can it be used?

  The Revolution Full Face Mask is designed to provide a sealed connection for continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) therapy, as well as for use as a ventilator interface in non-continuous (respirator) applications. It is intended for use in both home and institutional settings, such as hospitals, to ensure patient airway support during respiratory therapy.

• Is the Revolution Full Face Mask intended for single-use or reusable applications, and what cleaning protocols should be followed?

  The Revolution Full Face Mask is classified as a multi-patient reusable device. While specific sterility information is not provided, standard respiratory care protocols should be followed for cleaning and maintenance to ensure proper hygiene and functionality.

• How many different models or sizes of the Revolution Full Face Mask are available, and how can I identify them?

  The Revolution Full Face Mask comes in multiple models, as indicated by the extensive list of registration numbers (e.g., 3030970580, 3010440667, etc.). These numbers correspond to different variants or configurations, but the exact sizing or model-specific features (e.g., fit, material, or design) are not detailed in the provided data. For precise identification, refer to the manufacturer’s documentation or contact Respironics directly.

• What regulatory pathway was followed for the FDA clearance of the Revolution Full Face Mask, and what classification does it hold?

  The Revolution Full Face Mask received FDA clearance through a 510(k) Traditional pathway, specifically under K082866, and is classified as a Class II medical device. It falls under Regulation 868.5905 and is intended for use as a ventilator, non-continuous (respirator). The clearance was determined to be Substantially Equivalent (SESE) to a predicate device, as noted in the advisory committee description.

• Does the Revolution Full Face Mask have any special considerations for storage or handling beyond standard respiratory care practices?

  The provided data does not specify any unique storage requirements beyond adhering to standard respiratory care protocols. Since it is reusable, proper cleaning, disinfection, and storage in a clean, dry environment are recommended to maintain functionality and hygiene. Always follow the manufacturer’s instructions for optimal performance.