# K053352: Comfortlite Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Feb 15, 2006 after 75 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: 2 generations back to K945938 (1996). 6 ancestors in all.
41 later devices descend from it; 2 cite it directly.
7 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974453: Nasal Interface Model 7910, Healthdyne Technologies, Inc. (1998) Summary page 1.
- K992336: Monarch II Mini Mask, Respironics, Inc. (1999) Summary page 1.
- K032433: Nasal Jacks Mask, Resmed, Ltd. (2003) Summary page 1.

## Most influential descendants
- K082558: Comfortlite Nasal Mask (2009), 36 descendants of its own
- K102746: Mirage FX (2010), 19 descendants of its own
- K123979: Quattro Air (2013), 9 descendants of its own
- K102502: Golife Nasal Mask (2010), 9 descendants of its own
- K123789: Swift FX Nano (2013), 8 descendants of its own

## Indications for use
The ComfortLite Nasal Mask is intended to provide an interface for application of Respironics CPAP or bi-level therapy for the treatment of Obstructive Sleep Apnea. The mask is for use in the home or hospital/institutional environment on adults.

Source page: https://510kreport.com/device/K053352
Methodology: https://510kreport.com/methodology