510(k) · Cleared
ClearedAction Series Manual Wheelchairs, Various Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · IOR Wheelchair, Mechanical
Cleared on Oct 28, 1991 after a 17-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 28, 1991
- Review
- 17 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK914553 Action Series Manual Wheelchairs, Various ModelsInvacare Corp. · 1991
- Descendant · cites it directly · 2 of its ownK982336 Kuschall Design K3/K4 Series of Manual WheelchairsInvacare Corp. · 1998 · Recalled
- Descendant · cites it directly · 1 of its ownK041072 Kuschall Champion, Kuschall Compact, Kuschall Ultra-LightInvacare Corporation · 2004
- Descendant · 2 generations on · 0 of its ownK162686 Kuschall Champion Manual WheelchairInvacare Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK162692 Kuschall K-Series Attract Manual WheelchairInvacare Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK162696 Kuschall Advance Manual WheelchairInvacare Corporation · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K982336Kuschall Design K3/K4 Series of Manual WheelchairsInvacare Corp. · 1998 · cites it directly2descendants
- K041072Kuschall Champion, Kuschall Compact, Kuschall Ultra-LightInvacare Corporation · 2004 · cites it directly1descendant
- K162686Kuschall Champion Manual WheelchairInvacare Corporation · 2016 · 2 generations on0descendants
- K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation · 2016 · 2 generations on0descendants
- K162696Kuschall Advance Manual WheelchairInvacare Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914553 | Action Series Manual Wheelchairs, Various Models | Invacare Corp. | 1991 | — |
| +1 | K982336 | Kuschall Design K3/K4 Series of Manual Wheelchairs | Invacare Corp. | 1998 | 2 |
| +1 | K041072 | Kuschall Champion, Kuschall Compact, Kuschall Ultra-Light | Invacare Corporation | 2004 | — |
| +2 | K162686 | Kuschall Champion Manual Wheelchair | Invacare Corporation | 2016 | — |
| +2 | K162692 | Kuschall K-Series Attract Manual Wheelchair | Invacare Corporation | 2016 | — |
| +2 | K162696 | Kuschall Advance Manual Wheelchair | Invacare Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2016 | 3 | 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 IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
3 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, K982336 (Invacare Corp., 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
https://510kreport.com/device/K914553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914553: Action Series Manual Wheelchairs, Various Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914553
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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