# K082345: Oxygen Demand Valve

- Pathway: 510(k) (Traditional)
- Applicant: Bpr Medical, Ltd.
- Decided: Mar 13, 2009 after 210 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
The Carnet Oxygen Demand Valve is intended to be used for the delivery of 100% oxygen in response to the patient's inspiratory effort on the order of a physician. This product is designed for use with adult and paediatric patients in hospitals, ambulances or other managed clinical environments. This product is not intended to be used with infants or neonates.

Source page: https://510kreport.com/device/K082345
Methodology: https://510kreport.com/methodology