510(k) · Cleared
ClearedS9 Vpap ST with H5I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jan 5, 2011 as substantially equivalent to K080131 (Resmed, Ltd., 2008) and 2 other predicates after a 126-day review. Its family tree reaches back 8 generations to 1997. 11 later devices descend from it.
- Decided
- Jan 5, 2011
- Review
- 126 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K971260 (1997). 27 ancestors in all, the oldest K915460 (1993). 11 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 6 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 5 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 4 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 2 generations backK080131 Vpap STResmed, Ltd. · 2008
- 1 generation backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- This deviceK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · 2 generations on · 3 of its ownK153061 Juno VPAP ST-AResmed, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK140159 S9 Wanda Vpap STResmed, Ltd. · 2014
- Descendant · 3 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K113288Vpap ST-aResmed, Ltd. · 2012 · cites it directly7descendants
- K153061Juno VPAP ST-AResmed, Ltd. · 2016 · 2 generations on3descendants
- K140159S9 Wanda Vpap STResmed, Ltd. · 2014 · cites it directly2descendants
- K161492Juno VPAP ST-AResmed, Ltd. · 2017 · 3 generations on1descendant
- K123511S9 Vpap TXResmed, Ltd. · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −7 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −6 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −5 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −4 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −2 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −1 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| 0 (this device) | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| +1 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +2 | K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016 | — |
| +1 | K140159 | S9 Wanda Vpap ST | Resmed, Ltd. | 2014 | — |
| +3 | K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017 | — |
| +1 | K123511 | S9 Vpap TX | Resmed, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 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 BZD? 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 BZD device
- #1 K250624 myAirscore 15.7 · 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 |
|---|---|---|---|
| * | K080131 | Vpap STSummary page 2…known as Spontaneous (SMode), Timed (TMode), Spontaneous/Timed (SIT Mode) and VAuto Mode. Therapy modes come from the VPAP Tx system (K092186), VPAP ST (K080131) for S,SIT, Tand VAuto and CPAP Mode comes from the S8 Aspen (K091 947). ResMed… | 2008 |
| * | K091947 | S8 Aspen with H4I PlusSummary page 1…Proprietary Name S9 VPAP ST Predicate Devicels) VPAP ST (KOS0l 31). S8 Aspen with Hi Plus (K091 947) VPAP Tx (K092186) Reason for submission New Device I10t Nov, 2010… | 2009 |
| * | K092186 | Vpap TXSummary page 1…Predicate Devicels) VPAP ST (KOS0l 31). S8 Aspen with Hi Plus (K091 947) VPAP Tx (K092186) Reason for submission New Device I10t Nov, 2010… | 2009 |
What descends from it? (11)
See all 113 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 14 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K113288 (Resmed, Ltd., 2012) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K080131.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The S9 VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The S9 VPAP ST is intended for use in the hospital and home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102513: S9 Vpap ST with H5I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102513
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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