510(k) · Cleared
ClearedBipap Synchrony with Avaps
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 May 8, 2007 as substantially equivalent to K992530 (Respironics, Inc., 2000) and 2 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1997. 14 of the 67 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it.
- Decided
- May 8, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962517 (1997). 7 ancestors in all. 59 later devices descend from it, 4 citing it directly. 14 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 2 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 1 generation backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- This deviceK070328 Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 26 of its ownK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · cites it directly · 23 of its ownK090113 Breas Vivo 40 SystemBreas Medical AB · 2009
- Descendant · 2 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 2 generations on · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 14 of its ownK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 59 · See all- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly26descendants
- K090113Breas Vivo 40 SystemBreas Medical AB · 2009 · cites it directly23descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 2 generations on20descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on19descendants
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −2 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −1 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| 0 (this device) | K070328 | Bipap Synchrony with Avaps | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +1 | K090113 | Breas Vivo 40 System | Breas Medical AB | 2009 | — |
| +2 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +2 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +1 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 4 | 2 |
| 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.
14 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? (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 |
|---|---|---|---|
| * | K992530 | Bipap Synchrony HCSummary page 1…Proprietary Name Respironics BiPAP Synchrony with AVAPS Ventilatory Support System Predicate Device(s) Respironics BiPAP Synchrony HC (K992530) Respironics BiPAP Synchrony SIT (K012323/K020777) Reason for submission new… | 2000 |
| * | K012323 | Bipap Synchrony Ventilatory Support SystemSummary page 1…ilatory Support System Predicate Device(s) Respironics BiPAP Synchrony HC (K992530) Respironics BiPAP Synchrony SIT (K012323/K020777) Reason for submission new device (built on an existing cleared device platform) Substantial Equivalen… | 2001 |
| * | K020777 | Bipap Synchrony Ventilatory Support System with BI-FlexSummary page 1…Support System Predicate Device(s) Respironics BiPAP Synchrony HC (K992530) Respironics BiPAP Synchrony SIT (K012323/K020777) Reason for submission new device (built on an existing cleared device platform) Substantial Equivalence… | 2002 |
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (14 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.
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K152068Astral 100/150Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K083526 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 26 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 BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. 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.
For use in the home or hospital/institutional environment on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070328: Bipap Synchrony with Avaps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070328
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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