# K112126: Genuine First Aid CPR Mask

- Pathway: 510(k) (Traditional)
- Applicant: Genuine First Aid, LLC
- Decided: Dec 1, 2011 after 129 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). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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.
- K052458: Liv Medica CPR Face Mask, Liv Medica Products Pvt., Ltd. (2006) Summary page 1.

## Most influential descendants
- K142764: KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (2015), 1 descendant of its own
- K171961: Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) (2017), 0 descendants of its own

## Indications for use
The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring 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/K112126
Methodology: https://510kreport.com/methodology