# K925920: Total Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 21, 1993 after 240 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 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 no predicate by number.

## Most influential descendants
- K992969: Respironics Total Face Mask (1999), 15 descendants of its own
- K072588: Performax SE Total Face Mask (2007), 7 descendants of its own
- K072592: Performax Total Face Mask (2007), 6 descendants of its own
- K092648: Respironics Performax SE Total Face Mask (2009), 5 descendants of its own
- K092043: Bipap Synchrony 2 (2009), 4 descendants of its own

Source page: https://510kreport.com/device/K925920
Methodology: https://510kreport.com/methodology