# K970780: One-Way Valve (with Connector)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Sep 18, 1997 after 198 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.
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
Uni-directional valve to prevent back flow of gas in unintended, reverse direction toward source The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where “back flow” must be avoided. They are designed to prevent the flow of gas back toward the source.

Source page: https://510kreport.com/device/K970780
Methodology: https://510kreport.com/methodology