# K150639: AF541 EE Full Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Sep 18, 2015 after 191 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: 8 generations back to K962517 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101130: Bipap Synchrony 2 with AF531 Full Face Mask, Respironics, Inc. (2010) Summary page 4.

## Indications for use
This Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use i the hospital/institutional environment only. The mask is to be used on patients (=40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed. This Mask 1s intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment and single patient use in the home. The mask is to be used on patients (=401bs/20kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K150639
Methodology: https://510kreport.com/methodology