510(k) · Cleared
ClearedBipap Synchrony 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Aug 5, 2009 as substantially equivalent to K063533 (Respironics, Inc., 2007) and 2 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1997. 4 later devices descend from it.
- Decided
- Aug 5, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K962517 (1997). 20 ancestors in all, the oldest K833786 (1983). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 5 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 4 generations backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- 3 generations backK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- 2 generations backK063533 Bipap SynchronyRespironics, Inc. · 2007
- 1 generation backK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- This deviceK092043 Bipap Synchrony 2Respironics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101130 Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK150639 AF541 EE Full Face MaskRespironics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK120562 Performax Pediatric EE Total Face MaskRespironics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK103395 Performax Total Face MaskRespironics, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc. · 2010 · cites it directly1descendant
- K150639AF541 EE Full Face MaskRespironics, Inc. · 2015 · 2 generations on0descendants
- K120562Performax Pediatric EE Total Face MaskRespironics, Inc. · 2012 · cites it directly0descendants
- K103395Performax Total Face MaskRespironics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −5 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −4 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| −3 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| −2 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| −1 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| 0 (this device) | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | — |
| +1 | K101130 | Bipap Synchrony 2 with AF531 Full Face Mask | Respironics, Inc. | 2010 | — |
| +2 | K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015 | — |
| +1 | K120562 | Performax Pediatric EE Total Face Mask | Respironics, Inc. | 2012 | — |
| +1 | K103395 | Performax Total Face Mask | Respironics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K063533 | Bipap SynchronySummary page 1…MNS - Noncontinuous ventilator Predicate Device(s) Respironics BiPAP Synchrony 2 Ventilatory Support System (K063533/K071509) Respironics Performax Total Face Mask (K072592) Labeling Draft… | 2007 |
| * | K071509 | Bipap Synchrony 2 Ventilatory Support SystemSummary page 1…MNS - Noncontinuous ventilator Predicate Device(s) Respironics BiPAP Synchrony 2 Ventilatory Support System (K063533/K071509) Respironics Performax Total Face Mask (K072592) Labeling Draft Labeling… | 2007 |
| * | K072592 | Performax Total Face MaskSummary page 1…cs BiPAP Synchrony 2 Ventilatory Support System (K063533/K071509) Respironics Performax Total Face Mask (K072592) Labeling Draft Labeling can be found in Tab 5. Intended Use The Respironics BiPAP Sy… | 2007 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K101130 (Respironics, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K063533.
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 Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092043: Bipap Synchrony 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092043
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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