510(k) · Cleared
Recalled · Class III · 2014Devilbiss Intellipap / Sleepcube Auto Bilevel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devilbiss Healthcare, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Nov 22, 2011 as substantially equivalent to K082605 (Resmed, Ltd., 2009) and 2 other predicates after a 112-day review. Its family tree reaches back 8 generations to 1997. It has been recalled once.
- Decided
- Nov 22, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K971260 (1997). 26 ancestors in all, the oldest K915460 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 6 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 5 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 4 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 2 generations backK080131 Vpap STResmed, Ltd. · 2008
- 1 generation backK091919 Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 2009 · Recalled
- This deviceK112220 Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −7 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −6 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −5 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −4 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −2 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −1 | K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/ST | Sunrise Medical | 2009 | 1 |
| 0 (this device) | K112220 | Devilbiss Intellipap / Sleepcube Auto Bilevel | Devilbiss Healthcare, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K082605 | Vpap Auto with Humidaire 3ISummary page 3…ent of Safety and Effectiveness: Analysis of comparison of design, function and features of the proposed DeVilbiss DV57 Auto Bilevel to the predicates Resmed VPAP Auto (K082605), DeVilbiss DV55 Bilevel S (K091919) and DeVilbiss lntelliPAP/SleepCube DV54 AutoAdjust (# K071689), together with the results of… | 2009 |
| * | K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/STSummary page 3…alysis of comparison of design, function and features of the proposed DeVilbiss DV57 Auto Bilevel to the predicates Resmed VPAP Auto (K082605), DeVilbiss DV55 Bilevel S (K091919) and DeVilbiss lntelliPAP/SleepCube DV54 AutoAdjust (# K071689), together with the results of testing demonstrates the device to… | 2009 |
| * | K071689 | Devilbiss Intellipap Model DV 5 SeriesSummary page 1…s): DeVilbiss Intellipap Bilevel S - K(091919 DeVilbiss IntelliPAP Auto Adjust - K071689 Section 5.0 Page 1 of 3 Description of Device: The role of the product from… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K082605.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 lntelliPAP/SleepCube Model DV57 Series Auto Bilevel 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/K112220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112220: Devilbiss Intellipap / Sleepcube Auto Bilevel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112220
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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