510(k) · Cleared
ClearedTracer Series Manual Wheelchairs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · IOR Wheelchair, Mechanical
Cleared on Mar 1, 1994 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it.
- Decided
- Mar 1, 1994
- Review
- 112 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 12 citing it directly.
- This deviceK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
- Descendant · cites it directly · 22 of its ownK162621 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy…Invacare Corporation · 2017
- Descendant · 2 generations on · 21 of its ownK181795 AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018
- Descendant · 3 generations on · 12 of its ownK201461 Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021
- Descendant · cites it directly · 5 of its ownK982607 Manual WheelchairG. Hirsch and Co., Inc. · 1998
- Descendant · cites it directly · 4 of its ownK031910 Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…Invacare Corporation · 2017 · cites it directly22descendants
- K181795AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018 · 2 generations on21descendants
- K201461Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021 · 3 generations on12descendants
- K982607Manual WheelchairG. Hirsch and Co., Inc. · 1998 · cites it directly5descendants
- K031910Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935398 | Tracer Series Manual Wheelchairs | Invacare Corp. | 1994 | — |
| +1 | K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra… | Invacare Corporation | 2017 | — |
| +2 | K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2018 | — |
| +3 | K201461 | Manual Wheelchair, Model A011 | Ningbo Shenyu Medical Equipment Co.,Ltd | 2021 | — |
| +1 | K982607 | Manual Wheelchair | G. Hirsch and Co., Inc. | 1998 | — |
| +1 | K031910 | Stainless Steel Aquatic Wheelchair | Db Perks & Associates, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 9 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (41)
See all 4112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual… | 2017 | 22 |
| K982607 | Manual Wheelchair | 1998 | 5 |
| K031910 | Stainless Steel Aquatic Wheelchair | 2003 | 4 |
| K103212 | Roughrider | 2011 | 1 |
| K080207 | Danyang Huayi K2 and K7 Wheelchairs | 2008 | 1 |
| K032133 | Broda Model 587 Manual Wheelchair | 2003 | 1 |
| K130517 | EZ Transport Chair | 2014 | 0 |
| K120391 | MR4500 Wheelchair | 2012 | 0 |
| K081665 | Millenium II | 2008 | 0 |
| K052468 | YK9000 Series Manual Wheelchair | 2005 | 0 |
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, K162621 (Invacare Corporation, 2017) has gone furthest, with 22 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/K935398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935398: Tracer Series Manual Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935398
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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