510(k) · Cleared
ClearedBipap Harmony Ventilatory Support System
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 Jul 30, 2003 as substantially equivalent to K012323 (Respironics, Inc., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 1997. 14 of the 58 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it.
- Decided
- Jul 30, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962517 (1997). 5 ancestors in all. 52 later devices descend from it, 4 citing it directly. 14 of the 58 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 deviceK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- Descendant · cites it directly · 40 of its ownK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- Descendant · 2 generations on · 39 of its ownK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- Descendant · 3 generations on · 37 of its ownK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 35 of its ownK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 30 of its ownK063533 Bipap SynchronyRespironics, Inc. · 2007
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 52 · See all- K032834Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004 · cites it directly40descendants
- K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005 · 2 generations on39descendants
- K050759Bipap AutoRespironics, Inc. · 2005 · 3 generations on37descendants
- K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 4 generations on35descendants
- K063533Bipap SynchronyRespironics, Inc. · 2007 · cites it directly30descendants
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) | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| +1 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| +2 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| +3 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| +4 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 3 |
| 2010 | 3 | 1 |
| 2011 | 4 | 3 |
| 2012 | 6 | 3 |
| 2013 | 3 | 2 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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.
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? (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.
What descends from it? (52)
See all 524 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.
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 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 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K032834 (Respironics, Inc., 2004) has gone furthest, with 40 descendants of its own.
- 4 other devices also cite its predicate K012323.
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 BiPAP Harmony is intended to provide non-invasive ventilation in adult patients (>30kg) 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 BiPAP Harmony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031656: Bipap Harmony Ventilatory Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031656
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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