# K092835: Comfortgel Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Feb 12, 2010 after 150 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: 3 generations back to K833786 (1983). 7 ancestors in all.
10 later devices descend from it; 5 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073600: Comfortgel Full Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2008) Summary page 1.
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.

## Most influential descendants
- K110405: Trublue Nasal Mask (2011), 4 descendants of its own
- K122847: Kangaroo Nasal Mask (2013), 3 descendants of its own
- K140980: TI Nasal Mask (2015), 2 descendants of its own
- K210844: DreamWear Silicone Pillows Mask (2021), 1 descendant of its own
- K133009: Nasal Mask, Nasal Mask, Full Face Mask (2014), 1 descendant of its own

## Indications for use
The ComfortGel Blue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66IbsI3Okg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K092835
Methodology: https://510kreport.com/methodology