# K160112: Besmed PEEP Valve

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corp
- Decided: Apr 29, 2016 after 101 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Single patient use positive end expiratory pressure (PEEP) valve for use in hospital, transport, emergency, and post hospital care settings to evaluate end lung pressure above atmospheric pressure at the end of exhalation in constant and intermittent gas flow conditions.

Source page: https://510kreport.com/device/K160112
Methodology: https://510kreport.com/methodology