# K043282: Devilbiss Autoadjust, Model 9054 Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Feb 11, 2005 after 77 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 K971260 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950849: MODEL #7354, Devilbiss Health Care, Inc. (1996). Our OCR of the scanned summary read K980849, FDA’s number for Surgin Kit (Surgin Surgical Instrumentation, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DeVilbiss Model 7354 AutoAdjust CPAP with Remote Control Module”.
- K032056: Bilevel Cpap, Model 9055 Series, Sunrise Medical (2004) Summary page 4.
- K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink, Resmed, Ltd. (2003) Summary page 4.
- K032480: Autoset Spirit System, Resmed, Ltd. (2003) Summary page 4.

## Indications for use
The Model 9054 RPM AutoAdjust CPAP is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

Source page: https://510kreport.com/device/K043282
Methodology: https://510kreport.com/methodology