510(k) · Cleared
ClearedDevilbiss Autoadjust, Model 9054 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 11, 2005 as substantially equivalent to K950849 (Devilbiss Health Care, Inc., 1996) and 3 other predicates after a 77-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Feb 11, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K971260 (1997). 11 ancestors in all, the oldest K952491 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 2 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 1 generation backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- This deviceK043282 Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −2 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −1 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| 0 (this device) | K043282 | Devilbiss Autoadjust, Model 9054 Series | Sunrise Medical | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950849 | MODEL #7354 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”. | 1996 |
| * | K032056 | Bilevel Cpap, Model 9055 SeriesSummary page 4…arketed Predicate Devices: 510(k) Notification Device Name DeVilbiss Model 7354 AutoAdjust CPAP K9850849 with Remote Control Module DeVilbiss Model 9055 Bilevel CPAP K032056 Resmed AutoSet Spirit with Reslink K024191 Resmed AutoSet T K032480 11/22/2004 Section 11.0-1 Description of Devi… | 2004 |
| * | K024191 | S7 Elite and Autoset Spirit Cpap Systems with ReslinkSummary page 4…tion Device Name DeVilbiss Model 7354 AutoAdjust CPAP K9850849 with Remote Control Module DeVilbiss Model 9055 Bilevel CPAP K032056 Resmed AutoSet Spirit with Reslink K024191 Resmed AutoSet T K032480 11/22/2004 Section 11.0-1 Description of Device: The new DeVilbiss Model 9054 AutoAdjus… | 2003 |
| * | K032480 | Autoset Spirit SystemSummary page 4…iss Model 7354 AutoAdjust CPAP K9850849 with Remote Control Module DeVilbiss Model 9055 Bilevel CPAP K032056 Resmed AutoSet Spirit with Reslink K024191 Resmed AutoSet T K032480 11/22/2004 Section 11.0-1 Description of Device: The new DeVilbiss Model 9054 AutoAdjust CPAP is an AC powered b… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The Model 9054 RPM AutoAdjust CPAP is intended for use in treating
obstructive sleep apnea in patients 30 Kg and above.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043282: Devilbiss Autoadjust, Model 9054 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043282
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026