510(k) · Cleared
ClearedS9 Vpap Adapt 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 Mar 18, 2011 as substantially equivalent to K092186 (Resmed, Ltd., 2009) and 2 other predicates after a 190-day review. Its family tree reaches back 8 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 18, 2011
- Review
- 190 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). 6 later devices descend from it, 2 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 deviceK102586 S9 Vpap Adapt with H5IResmed, Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK113801 Vpap AdaptResmed Corp · 2012
- Descendant · 2 generations on · 2 of its ownK140279 S9 GreenhillsResmed, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK123511 S9 Vpap TXResmed, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK203126 S10 KirraResmed Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK160822 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K113801Vpap AdaptResmed Corp · 2012 · cites it directly5descendants
- K140279S9 GreenhillsResmed, Ltd. · 2014 · 2 generations on2descendants
- K123511S9 Vpap TXResmed, Ltd. · 2013 · 2 generations on1descendant
- K203126S10 KirraResmed Pty, Ltd. · 2020 · 3 generations on0descendants
- K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. · 2016 · cites it directly0descendants
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) | K102586 | S9 Vpap Adapt with H5I | Resmed, Ltd. | 2011 | — |
| +1 | K113801 | Vpap Adapt | Resmed Corp | 2012 | — |
| +2 | K140279 | S9 Greenhills | Resmed, Ltd. | 2014 | — |
| +2 | K123511 | S9 Vpap TX | Resmed, Ltd. | 2013 | — |
| +3 | K203126 | S10 Kirra | Resmed Pty, Ltd. | 2020 | — |
| +1 | K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV | Resmed, Ltd. | 2016 | — |
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 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K092186 | Vpap TXSummary page 1…GommonA~sual Name Non continuous ventilator (IPPB). Propriletary Name 89 VPAP Adapt Predicate Device(s) VPAP Tx (K092186) S8 Aspen with H4ll Plus (K(091 947) VPAP Adapt (… | 2009 |
| * | K091947 | S8 Aspen with H4I PlusSummary page 2…(s), using ablower based positive pressure system with an integrated heated humidifier and heater controller. The device platform issimilar to the 88 Aspen with Hi Plus (K091 947) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH 2Oas… | 2009 |
| * | K051364 | Vpap AdaptSummary page 2…erapy modes contained Inthe S9 VPAP Adapt are OPAP, OPAP with EPR, and Auto Servo Ventilation (ASV). Therapy modes come from the VPAP Tx system (K092186) and VPAP Adapt (K051364). The functional characteristics of the S9 VPAP Adapt system includes all the clinician and user firiendly features of the predi… | 2005 |
What descends from it? (6)
2 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 1.5 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K113801 (Resmed Corp, 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K092186.
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 Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102586: S9 Vpap Adapt 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/K102586
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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