# K992969: Respironics Total Face Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Nov 10, 1999 after 68 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 K925920 (1993). 1 ancestor in all.
15 later devices descend from it; 3 cite 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)
- K925920: Total Face Mask, Respironics, Inc. (1993). Our OCR of the scanned summary read K925320, FDA’s number for A-Dec 2145 Duo Unit, Cusp (A-Dec, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Total Face Mask”.

## Most influential descendants
- 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
- K101129: Esprit Ventilator with AF531 SE Full Face Mask (2010), 3 descendants of its own

## Indications for use
The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.

Source page: https://510kreport.com/device/K992969
Methodology: https://510kreport.com/methodology