# K152521: Seal Rite Non-Rebreathing Valve

- Pathway: 510(k) (Traditional)
- Applicant: The Lifeguard Store, Inc.
- Decided: Jun 3, 2016 after 274 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 K833748 (1983). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833748: Rescue Valve, Respironics, Inc. (1983) Summary page 4.

## Most influential descendants
- 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 Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.

Source page: https://510kreport.com/device/K152521
Methodology: https://510kreport.com/methodology