# K133957: Disposable Adjustable Peep Valve MR Conditional Use

- Pathway: 510(k) (Traditional)
- Applicant: Galemed Corp.
- Decided: Apr 14, 2014 after 112 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- 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 K902062 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082092: Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve, Galemed Corp. (2008) Summary page 1.
- K081266: Mercury Medical Peep Valve, Mercury Enterprizes Dba Mercury Medical (2009) Summary page 1.

## Indications for use
Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults. Environment of Use: Hospital. extended care facilities, emergency medical services, and patient transport May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Source page: https://510kreport.com/device/K133957
Methodology: https://510kreport.com/methodology