510(k) · Cleared
ClearedS9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
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 Sep 9, 2016 as substantially equivalent to K102586 (Resmed, Ltd., 2011) and 2 other predicates after a 169-day review. Its family tree reaches back 11 generations to 1997.
- Decided
- Sep 9, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K971260 (1997). 30 ancestors in all, the oldest K915460 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations between
- 3 generations backK102586 S9 Vpap Adapt with H5IResmed, Ltd. · 2011
- 2 generations backK113801 Vpap AdaptResmed Corp · 2012
- 1 generation backK140279 S9 GreenhillsResmed, Ltd. · 2014
- This deviceK160822 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. · 2016
Show all 11 generations
- Root · 11 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 10 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 9 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 8 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 7 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 5 generations backK080131 Vpap STResmed, Ltd. · 2008
- 4 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 3 generations backK102586 S9 Vpap Adapt with H5IResmed, Ltd. · 2011
- 2 generations backK113801 Vpap AdaptResmed Corp · 2012
- 1 generation backK140279 S9 GreenhillsResmed, Ltd. · 2014
- This deviceK160822 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −10 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −9 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −8 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −7 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −5 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −4 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| −3 | K102586 | S9 Vpap Adapt with H5I | Resmed, Ltd. | 2011 | — |
| −2 | K113801 | Vpap Adapt | Resmed Corp | 2012 | — |
| −1 | K140279 | S9 Greenhills | Resmed, Ltd. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K102586 | S9 Vpap Adapt with H5ISummary page 6…Common/Usual Name Non continuous ventilator (IPPB) Proprietary Name S9 VPAP Adapt Predicate device(s) S9 VPAP Adapt (K102586) ResMed Bundled 510(k) Premarket Notification K160822… | 2011 |
| * | K113801 | Vpap AdaptSummary page 10…Code 73 BZD Common/Usual Name Non continuous ventilator (IPPB) Proprietary Name VPAP Adapt Predicate device(s) VPAP Adapt (K113801) ResMed Bundled 510(k) Premarket Notification K160822… | 2012 |
| * | K140279 | S9 GreenhillsSummary page 14…Common/Usual Name Non continuous ventilator (IPPB) Proprietary Name AirCurve 10 ASV Predicate device(s) S9 Greenhills (K140279) ResMed Bundled 510(k) Premarket Notification K160822… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K102586.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Ib (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use. The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 1b (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and…
Read the full statement (135 words)
The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 Ib (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.
The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 1b (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
The VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160822: S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160822
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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