# K032056: Bilevel Cpap, Model 9055 Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Feb 20, 2004 after 233 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: 1 generation back to K952491 (1996). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952491: MODEL 7355, Devilbiss Health Care, Inc. (1996) Summary page 1.
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.
- K011229: Devilbiss 9000 Series Cpap, Model 9001, Sunrise Medical Hhg, Inc. (2001) Summary page 1.

## Most influential descendants
- K091919: Devilbiss Intellipap/Sleepcube Bilevel S/ST (2009), 1 descendant of its own
- K112220: Devilbiss Intellipap / Sleepcube Auto Bilevel (2011), 0 descendants of its own
- K093070: Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series (2010), 0 descendants of its own
- K043282: Devilbiss Autoadjust, Model 9054 Series (2005), 0 descendants of its own

## Indications for use
The Model 9055 Bilevel CPAP is intended for use in treating obstructive sleep apnea in adult patients.

Source page: https://510kreport.com/device/K032056
Methodology: https://510kreport.com/methodology