510(k) · Cleared
ClearedInvacare Power 9000 Series Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · ITI Wheelchair, Powered
Cleared on Feb 15, 1990 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- Feb 15, 1990
- Review
- 8 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 2 citing it directly.
- This deviceK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- Descendant · cites it directly · 18 of its ownK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- Descendant · 2 generations on · 17 of its ownK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
- Descendant · 3 generations on · 14 of its ownK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
- Descendant · 3 generations on · 9 of its ownK023589 Storm TDX Power WheelchairInvacare Corp. · 2002 · Recalled
- Descendant · 4 generations on · 4 of its ownK141783 TDX SP2 Power WheechairInvacare Corporation · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K982064Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998 · cites it directly18descendants
- K991168Arrow FWD Power WheelchairInvacare Corp. · 1999 · 2 generations on17descendants
- K012909Xterra GT Power WheelchairInvacare Corp. · 2001 · 3 generations on14descendants
- K023589Storm TDX Power WheelchairInvacare Corp. · 2002 · 3 generations on9descendants
- K141783TDX SP2 Power WheechairInvacare Corporation · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| +1 | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| +2 | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | 2 |
| +3 | K012909 | Xterra GT Power Wheelchair | Invacare Corp. | 2001 | — |
| +3 | K023589 | Storm TDX Power Wheelchair | Invacare Corp. | 2002 | 7 |
| +4 | K141783 | TDX SP2 Power Wheechair | Invacare Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 222 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?
- Of its descendants, K982064 (Invacare Corp., 1998) has gone furthest, with 18 descendants of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
https://510kreport.com/device/K900565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900565: Invacare Power 9000 Series Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900565
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026