510(k) · Cleared
ClearedVpap Adapt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Aug 16, 2005 as substantially equivalent to K033276 (Resmed, Ltd., 2004) after an 83-day review. Its family tree reaches back 2 generations to 1998. 2 of the 39 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Aug 16, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974417 (1998). 36 later devices descend from it, 5 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK974417 Sullivan Vpap II ST-a Nasal Vpap SystemResmed Corp · 1998
- 1 generation backK033276 Vpap Iii ST-aResmed, Ltd. · 2004
- This deviceK051364 Vpap AdaptResmed, Ltd. · 2005
- Descendant · cites it directly · 18 of its ownK092186 Vpap TXResmed, Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK063540 Bipap AutosvRespironics, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- Descendant · 2 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 36 · See all- K092186Vpap TXResmed, Ltd. · 2009 · cites it directly18descendants
- K063540Bipap AutosvRespironics, Inc. · 2007 · cites it directly13descendants
- K102513S9 Vpap ST with H5IResmed, Ltd. · 2011 · 2 generations on11descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 2 generations on10descendants
- K113288Vpap ST-aResmed, Ltd. · 2012 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974417 | Sullivan Vpap II ST-a Nasal Vpap System | Resmed Corp | 1998 | — |
| −1 | K033276 | Vpap Iii ST-a | Resmed, Ltd. | 2004 | — |
| 0 (this device) | K051364 | Vpap Adapt | Resmed, Ltd. | 2005 | — |
| +1 | K092186 | Vpap TX | Resmed, Ltd. | 2009 | — |
| +1 | K063540 | Bipap Autosv | Respironics, Inc. | 2007 | — |
| +2 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| +2 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +3 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 2 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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.
2 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? (1)
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 |
|---|---|---|---|
| * | K033276 | Vpap Iii ST-aSummary page 1…or, Passive Exhalation Port, Non-Critical Care. 21 CFR868.5895 Product Code 73MNS Predicate Devices: VPAP III ST-A (K033276) Reason for submission New device Intended Use: The VPAP ADAPT is intended to provide non-invasive… | 2004 |
What descends from it? (36)
See all 365 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092186 (Resmed, Ltd., 2009) has gone furthest, with 18 descendants of its own.
- 4 other devices also cite its predicate K033276.
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 VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051364: Vpap Adapt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051364
Report an extraction error
Are you the manufacturer?
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