# K150638: AF541 SE Full Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Sep 18, 2015 after 191 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K833786 (1983). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101129: Esprit Ventilator with AF531 SE Full Face Mask, Respironics, Inc. (2010) Summary page 4.

## Most influential descendants
- K243394: AF531 Oro-Nasal SE Face Mask (2024), 0 descendants of its own

## Indications for use
This Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

Source page: https://510kreport.com/device/K150638
Methodology: https://510kreport.com/methodology