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CPR Face Mask

by Genuine First Aid, LLC

510(k) K102299

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102299 Date18 Mar 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CBP
Device Class
Class II
Regulation
21 CFR Part 868.5870
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CPR Face Mask is a non-rebreathing valve device designed for mouth-to-mask ventilation. It serves as a barrier to direct expired air from a patient away from the user during cardiopulmonary resuscitation or oxygen support for non-breathing adults.

This device is intended for single use. It is authorized under FDA 510(k) number K102299.

Other devices from Genuine First Aid, LLC

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the CPR Face Mask?

    This device is designed for mouth-to-mask ventilation. It acts as a barrier to direct expired air from a patient away from the user during cardiopulmonary resuscitation or oxygen support for non-breathing adults.

  • Is the CPR Face Mask intended for multiple uses?

    No, this device is intended for single use only. It should be disposed of after a single application to maintain hygiene and prevent cross-contamination.

  • What is the regulatory status of this device?

    The CPR Face Mask is authorized under FDA 510(k) number K102299. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.