# K033914: Oxygen Diverter Valve

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Apr 22, 2004 after 126 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963250 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963250: Pressure Valve, Respironics, Inc. (1996) Summary page 1.
- K982530: Sullivan Mirage Full Face Mask, Resmed, Ltd. (1998) Summary page 1.

## Indications for use
The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating

Source page: https://510kreport.com/device/K033914
Methodology: https://510kreport.com/methodology