510(k) · Cleared
ClearedS8 Aspen with H4I Plus
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 28, 2009 as substantially equivalent to K080131 (Resmed, Ltd., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 1997. 31 later devices descend from it.
- Decided
- Sep 28, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971260 (1997). 21 ancestors in all, the oldest K915460 (1993). 31 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 5 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 4 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 2 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 1 generation backK080131 Vpap STResmed, Ltd. · 2008
- This deviceK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- Descendant · cites it directly · 11 of its ownK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- Descendant · cites it directly · 8 of its ownK140124 S9 EloueraResmed Corp · 2014
- Descendant · 2 generations on · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · 2 generations on · 6 of its ownK160836 Menai SystemResmed, Ltd. · 2016
- Descendant · cites it directly · 6 of its ownK102586 S9 Vpap Adapt with H5IResmed, Ltd. · 2011
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K102513S9 Vpap ST with H5IResmed, Ltd. · 2011 · cites it directly11descendants
- K140124S9 EloueraResmed Corp · 2014 · cites it directly8descendants
- K113288Vpap ST-aResmed, Ltd. · 2012 · 2 generations on7descendants
- K160836Menai SystemResmed, Ltd. · 2016 · 2 generations on6descendants
- K102586S9 Vpap Adapt with H5IResmed, Ltd. · 2011 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −6 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −5 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −4 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −2 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −1 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| 0 (this device) | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| +1 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| +1 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| +2 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +2 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| +1 | K102586 | S9 Vpap Adapt with H5I | Resmed, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 1…Common/Usual Name Non continuous ventilator (IPPB). Proprietary Name S8 Aspen Predicate Device(s) VPAP ST (K0801 31) VPAP Auto (K082605) Reason for submission New Device 25th June,… | 2008 |
| * | K082605 | Vpap Auto with Humidaire 3ISummary page 1…(IPPB). Proprietary Name S8 Aspen Predicate Device(s) VPAP ST (K0801 31) VPAP Auto (K082605) Reason for submission New Device 25th June, 2009… | 2009 |
What descends from it? (31)
See all 316 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 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K102513 (Resmed, Ltd., 2011) has gone furthest, with 11 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. 2009, 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 S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg).
The S8 Aspen self-adjusting system is intended for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091947 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091947: S8 Aspen with H4I Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091947
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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