510(k) · Cleared
ClearedElite Lightweight Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jaken Co., Inc. · IOR Wheelchair, Mechanical
Cleared on Dec 17, 1997 as substantially equivalent to K930412 (Everest & Jennings, Inc., 1993) after a 40-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 17, 1997
- Review
- 40 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930412 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930412 Premier 2 WheelchairEverest & Jennings, Inc. · 1993
- This deviceK974197 Elite Lightweight WheelchairJaken Co., Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930412 | Premier 2 Wheelchair | Everest & Jennings, Inc. | 1993 | — |
| 0 (this device) | K974197 | Elite Lightweight Wheelchair | Jaken Co., Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K930412 | Premier 2 WheelchairSummary page 3…manufactured by Everest and Jennings) is a legally marketed device which has been granted marketing clearance by FDA following the submission of a 510(k) number which is K930412. Please see Appendix |l for photographs and diagram of the two devices. The Elite wheelchair can travel on any hard surfaces suc… | 1993 |
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?
- Its one ancestor has no recall.
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?
OUR ELITE LIGHTWEIGHT WHEELCHAIR IS A MECHANICAL DEVICE THAT TRANSPORT OCCUPANTS WHO ARE IMMOBILE FROM ONE LOCATION TO ANOTHER. IN ORDER FOR ONE TO OPERATE THIS DEVICE AN ASSISTANT CAN PUSH THE WHEELCHAIR FROM BEHIND USING THE HANDLE BARS OR IF THE OCCUPANT HAS FUNCTION OF HIS/HER UPPER TORSO THEY CAN WHEEL THEMSELVES AROUND BY USING THE HANDRIMS THAT IS ATTACHED TO THE WHEELS.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974197: Elite Lightweight Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974197
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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