510(k) · Cleared
ClearedVpap ST-a
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 Mar 29, 2012 as substantially equivalent to K102513 (Resmed, Ltd., 2011) and 2 other predicates after a 143-day review. Its family tree reaches back 9 generations to 1997. 3 of the 108 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Mar 29, 2012
- Review
- 143 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K971260 (1997). 100 ancestors in all, the oldest K883038 (1988). 7 later devices descend from it, 3 citing it directly. 3 of the 108 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 5 generations between
- 3 generations backK080131 Vpap STResmed, Ltd. · 2008
- 2 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 1 generation backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- This deviceK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK153061 Juno VPAP ST-AResmed, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK161492 Juno VPAP ST-AResmed, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK123511 S9 Vpap TXResmed, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK251661 Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK213169 BPAP SystemBMC Medical Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 8 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 7 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 6 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 4 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 3 generations backK080131 Vpap STResmed, Ltd. · 2008
- 2 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 1 generation backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- This deviceK113288 Vpap ST-aResmed, Ltd. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K153061Juno VPAP ST-AResmed, Ltd. · 2016 · cites it directly3descendants
- K161492Juno VPAP ST-AResmed, Ltd. · 2017 · 2 generations on1descendant
- K123511S9 Vpap TXResmed, Ltd. · 2013 · cites it directly1descendant
- K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026 · 3 generations on0descendants
- K213169BPAP SystemBMC Medical Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −8 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −7 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −6 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −4 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −3 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −2 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| −1 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| 0 (this device) | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +1 | K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016 | — |
| +2 | K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017 | — |
| +1 | K123511 | S9 Vpap TX | Resmed, Ltd. | 2013 | — |
| +3 | K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty, Ltd. | 2026 | — |
| +2 | K213169 | BPAP System | BMC Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 2 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 1 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 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.
3 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? (3)
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 |
|---|---|---|---|
| * | K102513 | S9 Vpap ST with H5ISummary page 1…Ventilator, continuous, non-life-supporting Proprietary Name VPAP ST-A Predicate Device(s) ReaMed, VPAP ST with H5i (K102513) ReaMed, Stellar 150 (K103167) ReaMed, VPAP… | 2011 |
| * | K103167 | Stellar 150Summary page 1…ietary Name VPAP ST-A Predicate Device(s) ReaMed, VPAP ST with H5i (K102513) ReaMed, Stellar 150 (K103167) ReaMed, VPAP Ill ST-A (K033276) Reason for submission New Devi… | 2011 |
| * | K033276 | Vpap Iii ST-aSummary page 1…ed, VPAP ST with H5i (K102513) ReaMed, Stellar 150 (K103167) ReaMed, VPAP Ill ST-A (K033276) Reason for submission New Device 31 st Oct, 2011… | 2004 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 21 of the 100 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K153061 (Resmed, Ltd., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K102513.
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. 2012, 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 ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113288: Vpap ST-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113288
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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