# K980725: Exhalation Valve (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-a)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Aug 24, 1998 after 181 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K991788: Salter Labs Pep Device (1999), 0 descendants of its own

## Indications for use
Prevent escape of inspiratory gases and re-breathing of expired gases while providing a means of egress for expired gases

Source page: https://510kreport.com/device/K980725
Methodology: https://510kreport.com/methodology