# K081516: Medsource CPR Mask with & Without Oxygen Port

- Pathway: 510(k) (Traditional)
- Applicant: Medsource International, LLC
- Decided: Aug 26, 2008 after 88 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: 1 generation back to K861401 (1986). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861401: Laerdal Pocket Mask, Laerdal Medical Corp. (1986) Summary page 2.
- K042727: Pocket Size Resuscitator/Model: M16201R and M16201A, Foremount Ent. Co., Ltd. (2005) Summary page 2.
- (no number) Spiracle Pocket Size Resuscitator: named in the summary without a submission number

## Most influential descendants
- K112126: Genuine First Aid CPR Mask (2011), 2 descendants of its own
- 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
- K102299: CPR Face Mask (2011), 0 descendants of its own
- K083418: CPR Mask (2010), 0 descendants of its own

## Indications for use
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.

Source page: https://510kreport.com/device/K081516
Methodology: https://510kreport.com/methodology