# K091843: Comfort Twin Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Sep 10, 2009 after 80 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.
5 later devices descend from it; 1 cites 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)
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.
- K032916: Mirage Activa Mask, Resmed, Ltd. (2003) 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
- K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (2026), 0 descendants of its own

## 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. The mask is intended for single- patient reuse in the home environment or multi-patient, multi-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K091843
Methodology: https://510kreport.com/methodology