510(k) · Cleared
Recalled · 2007Bipap Synchrony Ventilatory Support System with BI-Flex
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 Mar 20, 2002 as substantially equivalent to K010263 (Respironics, Inc., 2001) and 1 other predicate after a 9-day review. Its family tree reaches back 2 generations to 2000. 15 of the 65 devices in its family, counting itself, have a Class I recall. 61 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 20, 2002
- Review
- 9 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000994 (2000). 3 ancestors in all. 61 later devices descend from it, 2 citing it directly. 15 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK000994 Bipap Duet LX BI-Level SystemRespironics, Inc. · 2000 · Recalled
- 1 generation backK011714 Bipap Pro BI-Level SystemRespironics, Inc. · 2001 · Recalled
- This deviceK020777 Bipap Synchrony Ventilatory Support System with BI-FlexRespironics, Inc. · 2002
- Descendant · cites it directly · 59 of its ownK070328 Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 2 generations on · 26 of its ownK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 23 of its ownK090113 Breas Vivo 40 SystemBreas Medical AB · 2009
- Descendant · 3 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 3 generations on · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 61 · See all- K070328Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly59descendants
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on26descendants
- K090113Breas Vivo 40 SystemBreas Medical AB · 2009 · 2 generations on23descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 3 generations on20descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000994 | Bipap Duet LX BI-Level System | Respironics, Inc. | 2000 | 1 |
| −1 | K011714 | Bipap Pro BI-Level System | Respironics, Inc. | 2001 | 1 |
| 0 (this device) | K020777 | Bipap Synchrony Ventilatory Support System with BI-Flex | Respironics, Inc. | 2002 | — |
| +1 | K070328 | Bipap Synchrony with Avaps | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +2 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +2 | K090113 | Breas Vivo 40 System | Breas Medical AB | 2009 | — |
| +3 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +3 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 3 |
| 2010 | 2 | 1 |
| 2011 | 4 | 2 |
| 2012 | 11 | 2 |
| 2013 | 4 | 1 |
| 2014 | 3 | 0 |
| 2016 | 6 | 1 |
| 2017 | 2 | 1 |
| 2018 | 2 | 1 |
| 2019 | 3 | 2 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
15 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? (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 |
|---|---|---|---|
| * | K010263 | Remstar Plus Cpap SystemSummary page 1…Ventilator, continuous, non-life supporting Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex Respironics BiPAP Synchrony Ventilatory Support System (K010263) Respironics BiPAP Pro System (K011714) Modified design, enhanced mode; change in environment of use. ©2002 Respironics Inc.… | 2001 |
| * | K011714 | Bipap Pro BI-Level SystemSummary page 1…ing Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex Respironics BiPAP Synchrony Ventilatory Support System (K010263) Respironics BiPAP Pro System (K011714) Modified design, enhanced mode; change in environment of use. ©2002 Respironics Inc. 3/8/2002 Page 27 of 73 R… | 2001 |
What descends from it? (61)
See all 612 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (15 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1061-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1088-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
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.
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K070328 (Respironics Inc., Sleep & Home Respiratory Group, 2007) has gone furthest, with 59 descendants of its own.
- 7 other devices also cite its predicate K010263.
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.
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 Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg)
for the treatment of respiratory insufficiency (a condition in which the patient can
continue without ventilation for some period, such as overnight) or obstructive sleep
apnea. The Synchrony may be used in the hospital or home.
The Synchrony is intended for use with nasal masks and full-face masks as
recommended by Respironics.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020777 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020777: Bipap Synchrony Ventilatory Support System with BI-Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020777
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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