510(k) · Cleared
ClearedModel 7700 Quantum Pressure Support Ventilator PSV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdyne Technologies, Inc. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Feb 20, 1997 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 56 of the 197 devices in its family, counting itself, have a Class I recall. 196 later devices descend from it.
- Decided
- Feb 20, 1997
- Review
- 238 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 0
196 later devices descend from it, 2 citing it directly. 56 of the 197 devices in this family, counting this one, have a Class I recall.
- This deviceK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- Descendant · cites it directly · 115 of its ownK984407 Bipap Harmony S/T, Model 1001445Respironics, Inc. · 1999
- Descendant · 2 generations on · 102 of its ownK022132 Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 92 of its ownK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- Descendant · 2 generations on · 91 of its ownK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- Descendant · 3 generations on · 75 of its ownK040221 Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled
Showing 5 of 196 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 196 · See all- K984407Bipap Harmony S/T, Model 1001445Respironics, Inc. · 1999 · cites it directly115descendants
- K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002 · 2 generations on102descendants
- K992530Bipap Synchrony HCRespironics, Inc. · 2000 · cites it directly92descendants
- K012323Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001 · 2 generations on91descendants
- K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| +1 | K984407 | Bipap Harmony S/T, Model 1001445 | Respironics, Inc. | 1999 | — |
| +2 | K022132 | Servo Ventilator System, Model 64 87 800 E407E | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| +2 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| +3 | K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 7 | 2 |
| 2005 | 4 | 0 |
| 2006 | 6 | 1 |
| 2007 | 9 | 0 |
| 2008 | 10 | 2 |
| 2009 | 13 | 6 |
| 2010 | 9 | 3 |
| 2011 | 17 | 11 |
| 2012 | 19 | 5 |
| 2013 | 12 | 6 |
| 2014 | 7 | 1 |
| 2015 | 8 | 1 |
| 2016 | 8 | 3 |
| 2017 | 8 | 4 |
| 2018 | 3 | 1 |
| 2019 | 8 | 3 |
| 2020 | 7 | 3 |
| 2021 | 8 | 3 |
| 2022 | 3 | 0 |
| 2023 | 6 | 1 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
56 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (196)
See all 1962 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (56 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.
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 113 Class I recalls
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 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
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 56 shown.
Nearest 5 of 56; all are on the web page.
What does this lineage say?
- Of its descendants, K984407 (Respironics, Inc., 1999) has gone furthest, with 115 descendants of its own.
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) | — |
https://510kreport.com/device/K962517 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962517: Model 7700 Quantum Pressure Support Ventilator PSV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962517
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026