# K091066: Comfort Twin Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Sep 3, 2009 after 142 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.
- K032916: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.

## Indications for use
The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

Source page: https://510kreport.com/device/K091066
Methodology: https://510kreport.com/methodology