510(k) · Cleared
ClearedBipap Synchrony 2 with AF531 Full Face Mask
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 Sep 2, 2010 as substantially equivalent to K092043 (Respironics, Inc., 2009) and 2 other predicates after a 133-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Sep 2, 2010
- Review
- 133 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962517 (1997). 22 ancestors in all, the oldest K833786 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 6 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 5 generations backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- 4 generations backK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- 3 generations backK063533 Bipap SynchronyRespironics, Inc. · 2007
- 2 generations backK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- 1 generation backK092043 Bipap Synchrony 2Respironics, Inc. · 2009
- This deviceK101130 Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK150639 AF541 EE Full Face MaskRespironics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150639AF541 EE Full Face MaskRespironics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −6 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −5 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| −4 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| −3 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| −2 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| −1 | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | — |
| 0 (this device) | K101130 | Bipap Synchrony 2 with AF531 Full Face Mask | Respironics, Inc. | 2010 | — |
| +1 | K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015 | — |
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 | 2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092043 | Bipap Synchrony 2Summary page 1…MNS - Continuous ventilator Predicate Device(s) Respironics BiPAP Synchrony 2 Ventilatory Support System (K092043) Respironics Pertormax Total Face Mask (K072592) Respironics… | 2009 |
| * | K072592 | Performax Total Face MaskSummary page 1…pironics BiPAP Synchrony 2 Ventilatory Support System (K092043) Respironics Pertormax Total Face Mask (K072592) Respironics Spectrum 2 Full Face Mask (K002465) Labeling Draft Labeli… | 2007 |
| * | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Summary page 1…(K092043) Respironics Pertormax Total Face Mask (K072592) Respironics Spectrum 2 Full Face Mask (K002465) Labeling Draft Labeling can be found in Tab 5. Intended Use The Respironics BiPAP… | 2000 |
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 |
|---|---|---|---|
| K150639 | AF541 EE Full Face Mask | 2015 | 0 |
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 1.8 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K150639 (Respironics, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K092043.
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 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/K101130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101130: Bipap Synchrony 2 with AF531 Full Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101130
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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