# K120639: Performax Pediatric SE Total Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 10, 2012 after 130 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 K902859 (1991). 49 ancestors in all.
No later device cites it as a predicate yet.
4 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092648: Respironics Performax SE Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 1.
- K093416: Trilogy 200 Ventilator, Respironics, Inc. (2010) Summary page 1.

## Indications for use
The PerforMax Pediatric 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 use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.

Source page: https://510kreport.com/device/K120639
Methodology: https://510kreport.com/methodology