510(k) · Cleared
ClearedBilevel Cpap, Model 9055 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 20, 2004 as substantially equivalent to K952491 (Devilbiss Health Care, Inc., 1996) and 2 other predicates after a 233-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 233 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K952491 (1996). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK952491 MODEL 7355Devilbiss Health Care, Inc. · 1996
- This deviceK032056 Bilevel Cpap, Model 9055 SeriesSunrise Medical · 2004
- Descendant · cites it directly · 1 of its ownK091919 Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK112220 Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK093070 Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical · 2010
- Descendant · cites it directly · 0 of its ownK043282 Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical · 2005
Most influential descendants
Showing 4 of 4 · See all- K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 2009 · cites it directly1descendant
- K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011 · 2 generations on0descendants
- K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical · 2010 · cites it directly0descendants
- K043282Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952491 | MODEL 7355 | Devilbiss Health Care, Inc. | 1996 | — |
| 0 (this device) | K032056 | Bilevel Cpap, Model 9055 Series | Sunrise Medical | 2004 | — |
| +1 | K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/ST | Sunrise Medical | 2009 | 1 |
| +2 | K112220 | Devilbiss Intellipap / Sleepcube Auto Bilevel | Devilbiss Healthcare, LLC | 2011 | 1 |
| +1 | K093070 | Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series | Sunrise Medical | 2010 | — |
| +1 | K043282 | Devilbiss Autoadjust, Model 9054 Series | Sunrise Medical | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K952491 | MODEL 7355Summary page 1…icate Devices: Device Name 510(k) Notification DeVilbiss Model 7355 Bilevel CPAP with Remote K952491 Control Module Resmed Sullivan VPAP II K961783 DeVilbiss 9001 Series CPAP… | 1996 |
| * | K961783 | Sullivan Vpap II ST Nasal Vpap SystemSummary page 1…cation DeVilbiss Model 7355 Bilevel CPAP with Remote K952491 Control Module Resmed Sullivan VPAP II K961783 DeVilbiss 9001 Series CPAP K011229 7/1/2003 Section… | 1996 |
| * | K011229 | Devilbiss 9000 Series Cpap, Model 9001Summary page 1…K952491 Control Module Resmed Sullivan VPAP II K961783 DeVilbiss 9001 Series CPAP K011229 7/1/2003 Section 16.0 - I Description of Device: The new DeVilbiss Model 905… | 2001 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K091919 (Sunrise Medical, 2009) has gone furthest, with 1 descendant of its own.
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 9055 Bilevel CPAP is intended for use in treating
obstructive sleep apnea in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032056: Bilevel Cpap, Model 9055 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032056
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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