# K120562: Performax Pediatric EE Total Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 17, 2012 after 144 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: 7 generations back to K962517 (1997). 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)
- K092043: Bipap Synchrony 2, Respironics, Inc. (2009) Summary page 1.
- K093416: Trilogy 200 Ventilator, Respironics, Inc. (2010) Summary page 2.

## Indications for use
PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. 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) for whom positive airway pressure therapy has been prescribed.

Source page: https://510kreport.com/device/K120562
Methodology: https://510kreport.com/methodology