# K073600: Comfortgel Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Apr 25, 2008 after 126 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: 1 generation back to K954207 (1996). 2 ancestors in all.
20 later devices descend from it; 4 cite it directly.
3 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.
- K954207: Gel Mask, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- K092835: Comfortgel Nasal Mask (2010), 10 descendants of its own
- K090935: Minime Pediatric Mask (2009), 5 descendants of its own
- K110405: Trublue Nasal Mask (2011), 4 descendants of its own
- K122847: Kangaroo Nasal Mask (2013), 3 descendants of its own
- K102224: Pixi Pediatric Mask (2010), 3 descendants of its own

## Indications for use
The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs/30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.

Source page: https://510kreport.com/device/K073600
Methodology: https://510kreport.com/methodology