510(k) · Cleared
ClearedWheelchair, Model 8500-II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cycling and Health Tech. Industry R&D Center · IOR Wheelchair, Mechanical
Cleared on Dec 13, 2004 as substantially equivalent to K012370 (Invacare Corp., 2001) after an 11-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 11 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941989 (1994). 5 ancestors in all, the oldest K934646 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK941989 Action at Manual WheelchairNvacare Corp. · 1994
- 2 generations backK984447 Model Action at II Manual WheelchairInvacare Corp. · 1999 · Recalled
- 1 generation backK012370 Solara JR. Manual WheelchairInvacare Corp. · 2001 · Recalled
- This deviceK043332 Wheelchair, Model 8500-IICycling and Health Tech. Industry R&D Center · 2004
- Descendant · cites it directly · 1 of its ownK082274 Haida Model HD11 Manual WheelchairJiangyin East China Medical Technology Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK100824 Mechanical Wheelchair, Model DS 202-SSuzhou KD Medical · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941989 | Action at Manual Wheelchair | Nvacare Corp. | 1994 | — |
| −2 | K984447 | Model Action at II Manual Wheelchair | Invacare Corp. | 1999 | 1 |
| −1 | K012370 | Solara JR. Manual Wheelchair | Invacare Corp. | 2001 | 3 |
| 0 (this device) | K043332 | Wheelchair, Model 8500-II | Cycling and Health Tech. Industry R&D Center | 2004 | — |
| +1 | K082274 | Haida Model HD11 Manual Wheelchair | Jiangyin East China Medical Technology Co., Ltd. | 2008 | — |
| +2 | K100824 | Mechanical Wheelchair, Model DS 202-S | Suzhou KD Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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 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? (1)
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 |
|---|---|---|---|
| * | K012370 | Solara JR. Manual WheelchairSummary page 2…lass I 7-1 Predicate devices Manufacture name: Invacare Corporation Name: Solara Jr. Wheelchair k number: K012370 Date cleared: 8/3/2001 Intend use of device AIDC 8500-1l Wheelchair is a tilt-in-space mobile positioning system for everyd… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082274 | Haida Model HD11 Manual Wheelchair | 2008 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K082274 (Jiangyin East China Medical Technology Co., Ltd., 2008) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K012370.
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 | — |
What is it indicated for?
AIDC 8500-LI Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043332: Wheelchair, Model 8500-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043332
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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