510(k) · Cleared
Recalled · Class III · 2014Devilbiss Intellipap/Sleepcube Bilevel S/ST
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 Sep 28, 2009 as substantially equivalent to K080131 (Resmed, Ltd., 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 28, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K971260 (1997). 17 ancestors in all, the oldest K930656 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 5 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 4 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 2 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 1 generation backK080131 Vpap STResmed, Ltd. · 2008
- This deviceK091919 Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 2009
- Descendant · cites it directly · 0 of its ownK112220 Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −6 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −5 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −4 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −2 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −1 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| 0 (this device) | K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/ST | Sunrise Medical | 2009 | — |
| +1 | K112220 | Devilbiss Intellipap / Sleepcube Auto Bilevel | Devilbiss Healthcare, LLC | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K080131 | Vpap STSummary page 1…68.5905 Ventilator, non- continuous respirator Predicate Device Name(s) and 5 10(k) Resmed VPAP ST - K080131 number(s): DeVilbiss 9055 Bilevel - K032056… | 2008 |
| * | K032056 | Bilevel Cpap, Model 9055 SeriesSummary page 1…us respirator Predicate Device Name(s) and 5 10(k) Resmed VPAP ST - K080131 number(s): DeVilbiss 9055 Bilevel - K032056 DeVilbiss Intellipap - K071689 Section 5… | 2004 |
| * | K071689 | Devilbiss Intellipap Model DV 5 SeriesSummary page 1…K080131 number(s): DeVilbiss 9055 Bilevel - K032056 DeVilbiss Intellipap - K071689 Section 5.0 Page 1 of 3 Description of Device: The role of the product from… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112220 | Devilbiss Intellipap / Sleepcube Auto Bilevel | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2014 | Class III | Z-1949-2014 | Software Manufacturing/Software Deployment | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K112220 (Devilbiss Healthcare, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K080131.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 DeVilbiss IntelliPAP/SleepCube Model DV55 S Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091919 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091919: Devilbiss Intellipap/Sleepcube Bilevel S/ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091919
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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