# K101129: Esprit Ventilator with AF531 SE Full Face Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Sep 16, 2010 after 147 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: 6 generations back to K833786 (1983). 17 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072588: Performax SE Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K092648: Respironics Performax SE Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 1.

## Most influential descendants
- K150638: AF541 SE Full Face Mask (2015), 1 descendant of its own
- K251888: VPAP Pediatric Face Mask (2026), 0 descendants of its own
- K243394: AF531 Oro-Nasal SE Face Mask (2024), 0 descendants of its own

## Indications for use
The small size AF531 SE Full Face 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 7 years or older (>40lbsI2Okg) who are appropriate candidates for noninvasive ventilation.

Source page: https://510kreport.com/device/K101129
Methodology: https://510kreport.com/methodology