# K072592: Performax Total Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Dec 19, 2007 after 96 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: 2 generations back to K925920 (1993). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992969: Respironics Total Face Mask, Respironics, Inc. (1999) Summary page 1.

## Most influential descendants
- K092043: Bipap Synchrony 2 (2009), 4 descendants of its own
- K101130: Bipap Synchrony 2 with AF531 Full Face Mask (2010), 1 descendant of its own
- K150639: AF541 EE Full Face Mask (2015), 0 descendants of its own
- K120562: Performax Pediatric EE Total Face Mask (2012), 0 descendants of its own
- K103395: Performax Total Face Mask (2011), 0 descendants of its own

## Indications for use
The Performax Total Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients. For multi-patient reuse in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs/30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP System. An exhalation port is built into this mask so that a separate exhalation port is not required. This mask is latex free and Di(2-ethylexyl)phthalate free.

Source page: https://510kreport.com/device/K072592
Methodology: https://510kreport.com/methodology