# K091271: Respironics Performax Total Face Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: May 29, 2009 after 29 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: 3 generations back to K925920 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072592: Performax Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.

## Indications for use
The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K091271
Methodology: https://510kreport.com/methodology