510(k) · Cleared
Recalled · Class I · 2024Bipap Autosv Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Oct 30, 2009 as substantially equivalent to K063540 (Respironics, Inc., 2007) and 1 other predicate after a 245-day review. Its family tree reaches back 5 generations to 1997. 1 of the 15 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Oct 30, 2009
- Review
- 245 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 2 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962517 (1997). 14 ancestors in all, the oldest K961783 (1996). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 4 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 3 generations backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- 2 generations backK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- 1 generation backK063533 Bipap SynchronyRespironics, Inc. · 2007
- This deviceK090539 Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −4 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −3 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| −2 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| −1 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| 0 (this device) | K090539 | Bipap Autosv Advanced | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K063540 | Bipap AutosvSummary page 1…or, continuous, non-life supporting Proprietary Name Respironics BiPAP AutoSV Advanced Predicate Device(s) Respironics BiPAP AutoSV (K063540) Respironics BiPAP Synchrony 2 (K063533) Reason for submission new device Su… | 2007 |
| * | K063533 | Bipap SynchronySummary page 1…pironics BiPAP AutoSV Advanced Predicate Device(s) Respironics BiPAP AutoSV (K063540) Respironics BiPAP Synchrony 2 (K063533) Reason for submission new device Substantial Equivalence The BiPAP AutoSV Advanced has the following simil… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2024 | Class I | Z-1817-2024 | Device Design | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death. |
| Aug 26, 2022 | Class I | Z-1658-2022 | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
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 2.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K063540.
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. 2009, 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 BiPAP AutoSV Advanced is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090539: Bipap Autosv Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090539
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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