510(k) · Cleared
ClearedS9 Vpap 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 Mar 21, 2013 as substantially equivalent to K113288 (Resmed, Ltd., 2012) and 3 other predicates after a 128-day review. Its family tree reaches back 10 generations to 1997. 3 of the 105 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Mar 21, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K971260 (1997). 103 ancestors in all, the oldest K883038 (1988). 1 later device descends from it, 1 citing it directly. 3 of the 105 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations between
- 3 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 2 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 1 generation backK113288 Vpap ST-aResmed, Ltd. · 2012
- This deviceK123511 S9 Vpap TXResmed, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK161487 VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd. · 2016
Show all 10 generations
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 9 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 8 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 7 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 4 generations backK080131 Vpap STResmed, Ltd. · 2008
- 3 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 2 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 1 generation backK113288 Vpap ST-aResmed, Ltd. · 2012
- This deviceK123511 S9 Vpap TXResmed, Ltd. · 2013
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −9 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −8 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −7 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −4 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −3 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| −2 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| −1 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| 0 (this device) | K123511 | S9 Vpap TX | Resmed, Ltd. | 2013 | — |
| +1 | K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | 2016 | — |
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 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K113288 | Vpap ST-aSummary page 1…on/Usual Name Ventilator, conuinuous, non-lik-supporing Proprietary Name 89 VPAP Tx Predicate Device(s) Reased, VPAP ST-A (1<113288) - Primary ResMed, VPAP ST (KI 0251 3)- Secondary ReaMed, 89 VPAP… | 2012 |
| * | K102513 | S9 Vpap ST with H5ISummary page 2…temnal communicating device%,Tissue/DoneDentin, contact duration 0*. Device Description The 69 VPAP Tx issimilar to mhe predicate devices VPAP ST-A (1(113288). VPAP ST (K102513), S9 VPAP Adapt (K1 13801) and S8 Aspen (K091 947). The S9 VPAP Tx provides CPAP, Auto-titrating, Silovel, VAuto and ASV modes to… | 2011 |
| * | K113801 | Vpap AdaptSummary page 1…Reased, VPAP ST-A (1<113288) - Primary ResMed, VPAP ST (KI 0251 3)- Secondary ReaMed, 89 VPAP Aapt (K1 13801) -Secondary ReaMed, 88 Aspen (K091 947) - Secondary Reason for submission New Device… | 2012 |
| * | K091947 | S8 Aspen with H4I PlusSummary page 1…ResMed, VPAP ST (KI 0251 3)- Secondary ReaMed, 89 VPAP Aapt (K1 13801) -Secondary ReaMed, 88 Aspen (K091 947) - Secondary Reason for submission New Device… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | 2016 | 0 |
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 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 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 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 21 of the 103 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K161487 (Resmed, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K113288.
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. 2013, 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 S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30 lb (13 kg); all other modes are indicated for patients weighing more than 66 lb (30 kg).
The S9 VPAP Tx is intended to be used in a clinical environment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123511: S9 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/K123511
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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