# K102299: CPR Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Genuine First Aid, LLC
- Decided: Mar 18, 2011 after 217 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861401 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081516: Medsource CPR Mask with & Without Oxygen Port, Medsource International, LLC (2008) Summary page 1.

## Indications for use
The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

Source page: https://510kreport.com/device/K102299
Methodology: https://510kreport.com/methodology