510(k) · Cleared
ClearedSullivan Vpap II ST Ventilatory Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Aug 6, 1998 after a 246-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 of the 27 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.
- Decided
- Aug 6, 1998
- Review
- 246 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly. 5 of the 27 devices in this family, counting this one, have a Class I recall.
- This deviceK974539 Sullivan Vpap II ST Ventilatory Support SystemResmed, Ltd. · 1998
- Descendant · cites it directly · 25 of its ownK053607 Breas Vivo 40 SystemBreas Medical AB · 2006
- Descendant · 2 generations on · 24 of its ownK071702 Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB · 2008
- Descendant · 3 generations on · 23 of its ownK090113 Breas Vivo 40 SystemBreas Medical AB · 2009
- Descendant · 4 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 5 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K053607Breas Vivo 40 SystemBreas Medical AB · 2006 · cites it directly25descendants
- K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB · 2008 · 2 generations on24descendants
- K090113Breas Vivo 40 SystemBreas Medical AB · 2009 · 3 generations on23descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 4 generations on20descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974539 | Sullivan Vpap II ST Ventilatory Support System | Resmed, Ltd. | 1998 | — |
| +1 | K053607 | Breas Vivo 40 System | Breas Medical AB | 2006 | — |
| +2 | K071702 | Breas Vivo Bilevel System, Model Vivo 40 | Breas Medical AB | 2008 | — |
| +3 | K090113 | Breas Vivo 40 System | Breas Medical AB | 2009 | — |
| +4 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +5 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 2 |
| 2013 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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.
5 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 MNT device
- #1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 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? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053607 | Breas Vivo 40 System | 2006 | 25 |
Has anything in its family been recalled? (5 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.
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K053607 (Breas Medical AB, 2006) has gone furthest, with 25 descendants of its own.
How does its category compare?
All MNT devicesMNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNT
Too few MNT 510(k)s in any year since 2007 to give a median.
Recalls per year · MNT
5in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
MAUDE reports naming product code MNT, 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 | 0 | — | 1 | 59 |
| 2008 | 1 | — | 0 | 76 |
| 2009 | 2 | — | 1 | 29 |
| 2010 | 0 | — | 1 | 63 |
| 2011 | 2 | — | 0 | 170 |
| 2012 | 2 | — | 0 | 257 |
| 2013 | 1 | — | 0 | 322 |
| 2014 | 0 | — | 0 | 887 |
| 2015 | 0 | — | 0 | 1,657 |
| 2016 | 0 | — | 0 | 2,515 |
| 2017 | 1 | — | 0 | 2,878 |
| 2018 | 0 | — | 0 | 2,203 |
| 2019 | 0 | — | 1 (1) | 9,350 |
| 2020 | 1 | — | 33 | 4,170 |
| 2021 | 0 | — | 0 | 3,790 |
| 2022 | 1 | — | 5 (5) | 3,277 |
| 2023 | 1 | — | 0 | 4,565 |
| 2024 | 2 | — | 0 | 4,808 |
| 2025 | 1 | — | 0 | 3,545 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SULLIVAN® VPAP™ II ST Ventilatory Support System is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.
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/K974539 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974539: Sullivan Vpap II ST Ventilatory Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974539
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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