510(k) · Cleared
ClearedS9 Wanda Vpap ST
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 Jun 17, 2014 as substantially equivalent to K102513 (Resmed, Ltd., 2011) after a 146-day review. Its family tree reaches back 9 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 17, 2014
- Review
- 146 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K971260 (1997). 28 ancestors in all, the oldest K915460 (1993). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK140159 S9 Wanda Vpap STResmed, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK203126 S10 KirraResmed Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK192177 SysMed S/TSysmed (China) Co., Ltd. · 2020
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 deviceK140159 S9 Wanda Vpap STResmed, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K140159 | S9 Wanda Vpap ST | Resmed, Ltd. | 2014 | — |
| +1 | K203126 | S10 Kirra | Resmed Pty, Ltd. | 2020 | — |
| +1 | K192177 | SysMed S/T | Sysmed (China) Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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? (1)
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…Class 11 Commonl~sual Name Non continuous ventilator (IPPB). Proprietary Name S9 WANDA VPAP ST Predicate Device(s) S9 VPAP ST (K1 02513) Reason for submission New Device Indication for Use The S9 WANDA VPAP ST isindicated for the treatment o… | 2011 |
What descends from it? (2)
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 17 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K203126 (Resmed Pty, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K102513.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for use in the hospital and home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140159: S9 Wanda Vpap ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140159
Report an extraction error
Are you the manufacturer?
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