# K072588: Performax SE Total Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Dec 18, 2007 after 95 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: 2 generations back to K925920 (1993). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992969: Respironics Total Face Mask, Respironics, Inc. (1999) Summary page 1.
- K023135: IMAGE3 SE Disposable Full Face Mask, Respironics, Inc. (2003) Summary page 1.

## Most influential descendants
- K092648: Respironics Performax SE Total Face Mask (2009), 5 descendants of its own
- K101129: Esprit Ventilator with AF531 SE Full Face Mask (2010), 3 descendants of its own
- 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 Performax SE Total 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 ventilator 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 multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

Source page: https://510kreport.com/device/K072588
Methodology: https://510kreport.com/methodology