# K042455: Devilbiss Nasal Cpap Mask, 9354 Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Jan 14, 2005 after 126 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 K982530 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954207: Gel Mask, Respironics, Inc. (1996) Summary page 1.
- K022642: Twlight, Model Isp 9600, Invacare Corp. (2003) Summary page 1.

## Indications for use
The new Nasal CPAP Mask is intended to be used with nasal continuous positive airway pressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of adult (> 30Kg) Obstructive Sleep Apnea (OSA). The device is to be used in home and clinical environments by or on order of a physician. The device can be used with auto-adjusting PAP devices which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.

Source page: https://510kreport.com/device/K042455
Methodology: https://510kreport.com/methodology