510(k) · Cleared
ClearedK5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest (ELR) 18” with elevated foot rest (ELR) 20” with elevated foot rest (ELR))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhenjiang Assure Medical Equipment Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Mar 31, 2026 as substantially equivalent to K232198 (Zhenjiang Assure Medical Equipment Co., Ltd., 2023) after a 60-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 31, 2026
- Review
- 60 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935398 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
- 4 generations backK162621 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy…Invacare Corporation · 2017
- 3 generations backK181795 AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018
- 2 generations backK201461 Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021
- 1 generation backK232198 Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
- This deviceK260319 K5 wheelchair (16” with swing-away footrest 18” with swing-away…Zhenjiang Assure Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935398 | Tracer Series Manual Wheelchairs | Invacare Corp. | 1994 | — |
| −4 | K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra… | Invacare Corporation | 2017 | — |
| −3 | K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2018 | — |
| −2 | K201461 | Manual Wheelchair, Model A011 | Ningbo Shenyu Medical Equipment Co.,Ltd | 2021 | — |
| −1 | K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S… | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023 | — |
| 0 (this device) | K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20”… | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S…Summary page 5…mation Classification Name: Mechanical Wheelchair Regulatory Class: I Product code: IOR Regulation Number: 890.3850 Review Panel: Physical Medicine 3. Predicate device: K232198 Zhenjiang Assure Medical Equipment Co., Ltd. Reclining wheelchair This predicate has not been subject to a design-related recall.… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K232198.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
The K5 Wheelchair is to provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260319: K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest (ELR) 18” with elevated foot rest (ELR) 20” with elevated foot rest (ELR)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260319
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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