# K082558: Comfortlite Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 25, 2009 after 202 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 K945938 (1996). 7 ancestors in all.
36 later devices descend from it; 5 cite it directly.
7 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053352: Comfortlite Nasal Mask, Respironics, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K132887: Airfit N10 (2013), 7 descendants of its own

## Indications for use
The ComfortLite 2 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs / 30 kg.

Source page: https://510kreport.com/device/K082558
Methodology: https://510kreport.com/methodology