510(k) · Cleared
ClearedBantex Brand Wheelchairs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bantex Corp. · IOR Wheelchair, Mechanical
Cleared on Jan 13, 1992 after a 55-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jan 13, 1992
- Review
- 55 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK915262 Bantex Brand WheelchairsBantex Corp. · 1992
- Descendant · cites it directly · 5 of its ownK982607 Manual WheelchairG. Hirsch and Co., Inc. · 1998
- Descendant · 2 generations on · 4 of its ownK031910 Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003
- Descendant · 3 generations on · 2 of its ownK051709 Hippocampe WheelchairVipamat Technologie · 2005
- Descendant · 4 generations on · 0 of its ownK251570 Hippocampe Marathon and TrailVipamat Sarl · 2025
- Descendant · 3 generations on · 0 of its ownK120302 Mechanical WheelchairNovaf Andalucia 2007, SL · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K982607Manual WheelchairG. Hirsch and Co., Inc. · 1998 · cites it directly5descendants
- K031910Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003 · 2 generations on4descendants
- K051709Hippocampe WheelchairVipamat Technologie · 2005 · 3 generations on2descendants
- K251570Hippocampe Marathon and TrailVipamat Sarl · 2025 · 4 generations on0descendants
- K120302Mechanical WheelchairNovaf Andalucia 2007, SL · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915262 | Bantex Brand Wheelchairs | Bantex Corp. | 1992 | — |
| +1 | K982607 | Manual Wheelchair | G. Hirsch and Co., Inc. | 1998 | — |
| +2 | K031910 | Stainless Steel Aquatic Wheelchair | Db Perks & Associates, Ltd. | 2003 | — |
| +3 | K051709 | Hippocampe Wheelchair | Vipamat Technologie | 2005 | — |
| +4 | K251570 | Hippocampe Marathon and Trail | Vipamat Sarl | 2025 | — |
| +3 | K120302 | Mechanical Wheelchair | Novaf Andalucia 2007, SL | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2025 | 1 | 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? (8)
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, K982607 (G. Hirsch and Co., Inc., 1998) has gone furthest, with 5 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/K915262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915262: Bantex Brand Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915262
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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