510(k) · Cleared
Recalled · Class II · 2015Arrow FWD 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 Jun 25, 1999 as substantially equivalent to K982064 (Invacare Corp., 1998) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1990. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 25, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900565 (1990). 3 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- 1 generation backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- This deviceK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999
- Descendant · cites it directly · 14 of its ownK012909 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 · cites it directly · 2 of its ownK012927 M71 Power WheelchairInvacare Corp. · 2001
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K012909Xterra GT Power WheelchairInvacare Corp. · 2001 · cites it directly14descendants
- 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
- K012927M71 Power WheelchairInvacare Corp. · 2001 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| −1 | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| 0 (this device) | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | — |
| +1 | 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 |
| +1 | K012927 | M71 Power Wheelchair | Invacare Corp. | 2001 | — |
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 |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K982064 | Action Storm Ranger II, Action Storm Power 9000Summary page 1…lassification Name Wheelchair, Powered Predicate Devices Invacare Corporations’ Action Storm Ranger II and Action Storm Power 9000 Front Wheel Drive Power Wheelchairs (K982064 , October 5, 1998) and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). Intended… | 1998 |
| * | K960951 | Permobil Chairman L/CS 8Summary page 1…Storm Ranger II and Action Storm Power 9000 Front Wheel Drive Power Wheelchairs (K982064 , October 5, 1998) and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). Intended Use _The intended use of the Invacare Arrow Front Wheel Drive Power Wheelchair is to p… | 1997 |
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2015 | Class II | Z-1138-2015 | Device Design | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a… |
| Apr 6, 2012 | Class II | Z-1905-2012 | Employee error | Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K012909 (Invacare Corp., 2001) has gone furthest, with 14 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 | — |
What is it indicated for?
Its intended use 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/K991168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991168: Arrow FWD Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991168
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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