# K963250: Pressure Valve

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Nov 14, 1996 after 87 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
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. The FDA summary names its predicate without a number.
- (no number) Instrumentation Industries, Inc. - Reusable One-Way Valve (Preamendment): named in the summary without a submission number

## Most influential descendants
- K033914: Oxygen Diverter Valve (2004), 0 descendants of its own

## Indications for use
To prevent backflow of oxygen or water from patient circuit into Respironics CPAP or BiPAP device when the unit is not functioning

Source page: https://510kreport.com/device/K963250
Methodology: https://510kreport.com/methodology