510(k) · Cleared
ClearedXterra GT Power 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 Oct 24, 2001 as substantially equivalent to K991168 (Invacare Corp., 1999) and 1 other predicate after a 55-day review. Its family tree reaches back 3 generations to 1990. 14 later devices descend from it.
- Decided
- Oct 24, 2001
- Review
- 55 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K900565 (1990). 4 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- 2 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- 1 generation backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
- This deviceK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
- Descendant · cites it directly · 9 of its ownK023589 Storm TDX Power WheelchairInvacare Corp. · 2002 · Recalled
- Descendant · 2 generations on · 4 of its ownK141783 TDX SP2 Power WheechairInvacare Corporation · 2015
- Descendant · 3 generations on · 3 of its ownK170507 Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX…Invacare Corporation · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK192216 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK092225 Amypower All Track Series Power WheelchairAmylior, Inc. · 2009
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K023589Storm TDX Power WheelchairInvacare Corp. · 2002 · cites it directly9descendants
- K141783TDX SP2 Power WheechairInvacare Corporation · 2015 · 2 generations on4descendants
- K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…Invacare Corporation · 2017 · 3 generations on3descendants
- K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 2020 · 4 generations on1descendant
- K092225Amypower All Track Series Power WheelchairAmylior, Inc. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| −2 | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| −1 | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | 2 |
| 0 (this device) | K012909 | Xterra GT Power Wheelchair | Invacare Corp. | 2001 | — |
| +1 | K023589 | Storm TDX Power Wheelchair | Invacare Corp. | 2002 | 7 |
| +2 | K141783 | TDX SP2 Power Wheechair | Invacare Corporation | 2015 | — |
| +3 | K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics… | Invacare Corporation | 2017 | 2 |
| +4 | K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | Invacare Corporation | 2020 | 1 |
| +2 | K092225 | Amypower All Track Series Power Wheelchair | Amylior, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 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), 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 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? (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 |
|---|---|---|---|
| * | K991168 | Arrow FWD Power WheelchairSummary page 1…Common or Usual Name Power Wheelchair Classification Name Wheelchair, Powered Predicate Devices Invacare Corporations’ Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999) and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). KOl 29019 QA… | 1999 |
| * | K960951 | Permobil Chairman L/CS 8Summary page 1…cate Devices Invacare Corporations’ Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999) and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). KOl 29019 QAOFS Intended Use The intended use of the Invacare Model Xterra GT Power Wheelchair… | 1997 |
What descends from it? (14)
See all 143 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 11 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K023589 (Invacare Corp., 2002) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K991168.
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 | — |
What is it indicated for?
The intended use of the Invacare ZX2 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
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/K012909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012909: Xterra GT Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012909
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026