510(k) · Cleared
ClearedBipap Synchrony
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 Feb 20, 2007 as substantially equivalent to K992530 (Respironics, Inc., 2000) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1997. 8 of the 42 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it.
- Decided
- Feb 20, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962517 (1997). 11 ancestors in all, the oldest K961783 (1996). 30 later devices descend from it, 4 citing it directly. 8 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 3 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 2 generations backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- 1 generation backK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- This deviceK063533 Bipap SynchronyRespironics, Inc. · 2007
- Descendant · cites it directly · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- Descendant · 2 generations on · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 3 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 4 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly28descendants
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations on11descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · cites it directly10descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on8descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −3 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −2 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| −1 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| 0 (this device) | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| +1 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| +2 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| +1 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +4 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 1 |
| 2010 | 3 | 1 |
| 2011 | 3 | 2 |
| 2012 | 5 | 2 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
8 devices in this family have 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? (4)
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 |
|---|---|---|---|
| * | K992530 | Bipap Synchrony HCSummary page 1…supporting Proprietary Name Respironics BiPAP Synchrony 2 Ventilatory Support System Predicate Device(s) Respironics BiPAP Synchrony HO (K992530) Respironics BIPAP Synchrony SIT (K012323) Respironics BiPA… | 2000 |
| * | K012323 | Bipap Synchrony Ventilatory Support SystemSummary page 1…entilatory Support System Predicate Device(s) Respironics BiPAP Synchrony HO (K992530) Respironics BIPAP Synchrony SIT (K012323) Respironics BiPAP Harmony (K031 656) Resmed VPAP Ill ST-Al… | 2001 |
| * | K031656 | Bipap Harmony Ventilatory Support SystemSummary page 1…s BiPAP Synchrony HO (K992530) Respironics BIPAP Synchrony SIT (K012323) Respironics BiPAP Harmony (K031 656) Resmed VPAP Ill ST-Al/ Kidsta system (K0601 05) Reason for submission Include p… | 2003 |
| * | K060105 | Vpap Iii ST-a/Kidsta Mask SystemSummary page 1…Synchrony SIT (K012323) Respironics BiPAP Harmony (K031 656) Resmed VPAP Ill ST-Al/ Kidsta system (K0601 05) Reason for submission Include pediatric (7 years and older, > 40 lbs) indication. Substantial Equivalence The… | 2006 |
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K071509 (Respironics Inc., Sleep & Home Respiratory Group, 2007) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K992530.
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. 2007, 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/K063533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063533: Bipap Synchrony.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063533
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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