510(k) · Cleared
ClearedVpap TX
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 Dec 22, 2009 as substantially equivalent to K051364 (Resmed, Ltd., 2005) and 3 other predicates after a 154-day review. Its family tree reaches back 7 generations to 1997. 18 later devices descend from it.
- Decided
- Dec 22, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K971260 (1997). 17 ancestors in all, the oldest K930656 (1994). 18 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 5 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 4 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 2 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 1 generation backK080131 Vpap STResmed, Ltd. · 2008
- This deviceK092186 Vpap TXResmed, Ltd. · 2009
- Descendant · cites it directly · 11 of its ownK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK102586 S9 Vpap Adapt with H5IResmed, Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK113801 Vpap AdaptResmed Corp · 2012
- Descendant · 3 generations on · 3 of its ownK153061 Juno VPAP ST-AResmed, Ltd. · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K102513S9 Vpap ST with H5IResmed, Ltd. · 2011 · cites it directly11descendants
- K113288Vpap ST-aResmed, Ltd. · 2012 · 2 generations on7descendants
- K102586S9 Vpap Adapt with H5IResmed, Ltd. · 2011 · cites it directly6descendants
- K113801Vpap AdaptResmed Corp · 2012 · 2 generations on5descendants
- K153061Juno VPAP ST-AResmed, Ltd. · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −6 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −5 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −4 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −2 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −1 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| 0 (this device) | K092186 | Vpap TX | Resmed, Ltd. | 2009 | — |
| +1 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| +2 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +1 | K102586 | S9 Vpap Adapt with H5I | Resmed, Ltd. | 2011 | — |
| +2 | K113801 | Vpap Adapt | Resmed Corp | 2012 | — |
| +3 | K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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.
Planning a device in MNS? 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? (4)
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 |
|---|---|---|---|
| * | K051364 | Vpap AdaptSummary page 1…73 MNS Common/Usual Name Ventilator, continuous, non-life-supporting Proprietary Name VPAP Tx Predicate Device(s) VPAP Adapt (K051364) - Primary VS (VPAP ST) (K080131) - Secondary VPAP Ill ST-A (K03327… | 2005 |
| * | K080131 | Vpap STSummary page 1…non-life-supporting Proprietary Name VPAP Tx Predicate Device(s) VPAP Adapt (K051364) - Primary VS (VPAP ST) (K080131) - Secondary VPAP Ill ST-A (K033276) - Secondary AutoSet Clinical (… | 2008 |
| * | K033276 | Vpap Iii ST-aSummary page 1…Predicate Device(s) VPAP Adapt (K051364) - Primary VS (VPAP ST) (K080131) - Secondary VPAP Ill ST-A (K033276) - Secondary AutoSet Clinical (K952429) - Secondary Reason for submission New Device… | 2004 |
| * | K952429 | Res Care Auto Set Clinical, Portable System, Portable 2 SystemSummary page 1…VS (VPAP ST) (K080131) - Secondary VPAP Ill ST-A (K033276) - Secondary AutoSet Clinical (K952429) - Secondary Reason for submission New Device 15 July, 2009… | 1996 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K102513 (Resmed, Ltd., 2011) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K051364.
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. 2009, this device’s year, is highlighted.
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 Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.
The VPAP Tx is intended to be used in a clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092186: Vpap TX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092186
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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