# K955520: Rescue Breather

- Pathway: 510(k) (Traditional)
- Applicant: International Safety, Inc.
- Decided: Oct 8, 1996 after 309 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 K900260 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900260: Ambu Life Key and Ambu Res-Cue Key, Ambu, Inc. (1990) Summary page 1.

## Indications for use
The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile.

Source page: https://510kreport.com/device/K955520
Methodology: https://510kreport.com/methodology