510(k) · Cleared
ClearedSullivan Vpap II ST-a Nasal Vpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Corp · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Jun 24, 1998 after a 212-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 of the 71 devices in its family, counting itself, have a Class I recall. 70 later devices descend from it.
- Decided
- Jun 24, 1998
- Review
- 212 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 0
70 later devices descend from it, 2 citing it directly. 10 of the 71 devices in this family, counting this one, have a Class I recall.
- This deviceK974417 Sullivan Vpap II ST-a Nasal Vpap SystemResmed Corp · 1998
- Descendant · cites it directly · 68 of its ownK033276 Vpap Iii ST-aResmed, Ltd. · 2004
- Descendant · 2 generations on · 53 of its ownK060105 Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd. · 2006
- Descendant · 2 generations on · 36 of its ownK051364 Vpap AdaptResmed, Ltd. · 2005
- Descendant · 3 generations on · 30 of its ownK063533 Bipap SynchronyRespironics, Inc. · 2007
- Descendant · 4 generations on · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 70 · See all- K033276Vpap Iii ST-aResmed, Ltd. · 2004 · cites it directly68descendants
- K060105Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd. · 2006 · 2 generations on53descendants
- K051364Vpap AdaptResmed, Ltd. · 2005 · 2 generations on36descendants
- K063533Bipap SynchronyRespironics, Inc. · 2007 · 3 generations on30descendants
- K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974417 | Sullivan Vpap II ST-a Nasal Vpap System | Resmed Corp | 1998 | — |
| +1 | K033276 | Vpap Iii ST-a | Resmed, Ltd. | 2004 | — |
| +2 | K060105 | Vpap Iii ST-a/Kidsta Mask System | Resmed, Ltd. | 2006 | — |
| +2 | K051364 | Vpap Adapt | Resmed, Ltd. | 2005 | — |
| +3 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| +4 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 7 | 2 |
| 2010 | 5 | 1 |
| 2011 | 7 | 2 |
| 2012 | 12 | 2 |
| 2013 | 4 | 1 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 1 |
| 2020 | 4 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
10 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (70)
See all 702 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 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 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 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
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- Of its descendants, K033276 (Resmed, Ltd., 2004) has gone furthest, with 68 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) | — |
What is it indicated for?
The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974417 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974417: Sullivan Vpap II ST-a Nasal Vpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974417
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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