510(k) · Cleared
ClearedDevilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Jan 26, 2010 as substantially equivalent to K080131 (Resmed, Ltd., 2008) and 2 other predicates after a 118-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Jan 26, 2010
- Review
- 118 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K971260 (1997). 17 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet.
- 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 deviceK093070 Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical · 2010
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) | K093070 | Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series | Sunrise Medical | 2010 | — |
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 |
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 MNS? 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 MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 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…95 ventilator, continuous, non-life-supporting Predicate Device Name(s) and 5 10(k) Resmed VPAP ST - K080 131 number(s): DeVilbiss 9055 Bilevel - K032056… | 2008 |
| * | K032056 | Bilevel Cpap, Model 9055 SeriesSummary page 1…e-supporting Predicate Device Name(s) and 5 10(k) Resmed VPAP ST - K080 131 number(s): DeVilbiss 9055 Bilevel - K032056 DeVilbiss Intellipap - K07 1689 Section… | 2004 |
| * | K071689 | Devilbiss Intellipap Model DV 5 SeriesSummary page 1…080 131 number(s): DeVilbiss 9055 Bilevel - K032056 DeVilbiss Intellipap - K07 1689 Section 5.0 Page 1 of 3 Description of Device: The role of the product fro… | 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)
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 13 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.
- 4 other devices also cite its predicate K080131.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The DeVilbiss IntelliPAPISleep~ube Model DV56 ST Series 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/K093070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093070: Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093070
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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