510(k) · Cleared
Recalled · Class II · 2015Invacare Powered Wheelchairs, Models M50, M51, M71 & M91
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 18, 2002 as substantially equivalent to K012909 (Invacare Corp., 2001) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jun 18, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 4 generations to K900565 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- 3 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- 2 generations backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
- 1 generation backK012927 M71 Power WheelchairInvacare Corp. · 2001
- This deviceK021680 Invacare Powered Wheelchairs, Models M50, M51, M71 & M91Invacare Corp. · 2002
- Descendant · cites it directly · 0 of its ownK080385 Cruiser PP5500 Challenger Powered WheelchairE1 Ent., Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080385Cruiser PP5500 Challenger Powered WheelchairE1 Ent., Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| −3 | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| −2 | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | 2 |
| −1 | K012927 | M71 Power Wheelchair | Invacare Corp. | 2001 | — |
| 0 (this device) | K021680 | Invacare Powered Wheelchairs, Models M50, M51, M71 & M91 | Invacare Corp. | 2002 | — |
| +1 | K080385 | Cruiser PP5500 Challenger Powered Wheelchair | E1 Ent., Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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 |
|---|---|---|---|
| * | K012909 | Xterra GT Power WheelchairSummary page 1…-NX controller are substantially equivalent to devices that are currently being legally marketed within the United States, including Invacare Xterra GT power wheelchair (K012909, 10/24/2001) and the hvacpre Pronto M71 power wheelchair (K012927). Intended Use The intended fbnction and use is to provide mob… | 2001 |
| * | K012927 | M71 Power WheelchairSummary page 1…rrently being legally marketed within the United States, including Invacare Xterra GT power wheelchair (K012909, 10/24/2001) and the hvacpre Pronto M71 power wheelchair (K012927). Intended Use The intended fbnction and use is to provide mobility to persons limited to a sitting position that have the capab… | 2001 |
| † | K940972 | Model MCC - Mkiv Micro Computer Controls | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080385 | Cruiser PP5500 Challenger Powered Wheelchair | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2015 | Class II | Z-2358-2015 | Device Design | The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use… |
| Jun 24, 2014 | Class II | Z-2091-2014 | Process control | M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max… |
| Jun 14, 2006 | Not classified | Z-1400-06 | Other | Some of the wheelchairs were distributed with seats that did not have a seat positioning strap. |
| May 2, 2005 | Not classified | Z-0902-05 | Other | If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if… |
| May 2, 2005 | Not classified | Z-0901-05 | Other | If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if… |
| May 2, 2005 | Not classified | Z-0903-05 | Other | If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K080385 (E1 Ent., Inc., 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K012909.
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 function and use is to provide mobility to persons limited to a sitting position that have capability of operating a powered wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021680: Invacare Powered Wheelchairs, Models M50, M51, M71 & M91.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021680
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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