# K142402: BigEasy Non-Rebreathing Valve

- Pathway: 510(k) (Traditional)
- Applicant: 12th Man Technologies, Inc.
- Decided: Mar 23, 2015 after 208 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). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K842693: Respironics Venteasy, Respironics, Inc. (1984) Summary page 4.

## Indications for use
The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.

Source page: https://510kreport.com/device/K142402
Methodology: https://510kreport.com/methodology