# K092648: Respironics Performax SE Total Face Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Dec 18, 2009 after 112 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: 5 generations back to K833786 (1983). 16 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072450: Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000, Respironics California, Inc. (2007) Summary page 1.
- K072588: Performax SE Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.

## Most influential descendants
- 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
- K120639: Performax Pediatric SE Total Face Mask (2012), 0 descendants of its own

## Indications for use
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in. either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 6OLJmin.

Source page: https://510kreport.com/device/K092648
Methodology: https://510kreport.com/methodology