# K103395: Performax Total Face Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Mar 24, 2011 after 125 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: 7 generations back to K962517 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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.
- K092043: Bipap Synchrony 2, Respironics, Inc. (2009) Summary page 2.

## Indications for use
The PerforMax Total Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. For multi-patient, multi-use in the hospital/institutional environment or single patient reuse in the home. The mask is to be used on patients 7 years or older (>40 lbs/18.2 kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K103395
Methodology: https://510kreport.com/methodology