510(k) · Cleared
ClearedStainless Steel Aquatic Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Db Perks & Associates, Ltd. · IOR Wheelchair, Mechanical
Cleared on Jul 25, 2003 as substantially equivalent to K935398 (Invacare Corp., 1994) and 1 other predicate after a 35-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jul 25, 2003
- Review
- 35 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915262 (1992). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK915262 Bantex Brand WheelchairsBantex Corp. · 1992
- 1 generation backK982607 Manual WheelchairG. Hirsch and Co., Inc. · 1998
- This deviceK031910 Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK051709 Hippocampe WheelchairVipamat Technologie · 2005
- Descendant · 2 generations on · 0 of its ownK251570 Hippocampe Marathon and TrailVipamat Sarl · 2025
- Descendant · cites it directly · 0 of its ownK120302 Mechanical WheelchairNovaf Andalucia 2007, SL · 2012
- Descendant · cites it directly · 0 of its ownK101217 Mac-Mobile Aquatic ChairRehamed Intl., LLC · 2010
Most influential descendants
Showing 4 of 4 · See all- K051709Hippocampe WheelchairVipamat Technologie · 2005 · cites it directly2descendants
- K251570Hippocampe Marathon and TrailVipamat Sarl · 2025 · 2 generations on0descendants
- K120302Mechanical WheelchairNovaf Andalucia 2007, SL · 2012 · cites it directly0descendants
- K101217Mac-Mobile Aquatic ChairRehamed Intl., LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915262 | Bantex Brand Wheelchairs | Bantex Corp. | 1992 | — |
| −1 | K982607 | Manual Wheelchair | G. Hirsch and Co., Inc. | 1998 | — |
| 0 (this device) | K031910 | Stainless Steel Aquatic Wheelchair | Db Perks & Associates, Ltd. | 2003 | — |
| +1 | K051709 | Hippocampe Wheelchair | Vipamat Technologie | 2005 | — |
| +2 | K251570 | Hippocampe Marathon and Trail | Vipamat Sarl | 2025 | — |
| +1 | K120302 | Mechanical Wheelchair | Novaf Andalucia 2007, SL | 2012 | — |
| +1 | K101217 | Mac-Mobile Aquatic Chair | Rehamed Intl., LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K935398 | Tracer Series Manual WheelchairsSummary page 2…m-aquaticcom Predicate device: A) Tracer EX Manual Wheelchair - lnvacare granted clearance by FDA March 01, 1994 under 510K # K935398. B) Silhouette 300 Manual Wheelchair - G Hirsch & Co. granted clearance by FDA August 31, 1998 under 5… | 1994 |
| * | K982607 | Manual WheelchairSummary page 2…01, 1994 under 510K # K935398. B) Silhouette 300 Manual Wheelchair - G Hirsch & Co. granted clearance by FDA August 31, 1998 under 51OK # K982607. Intended Use: This wheelchair is to provide mobility to persons limited to a sitting position being… | 1998 |
What descends from it? (4)
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051709 (Vipamat Technologie, 2005) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K935398.
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?
This wheelchair is to provide mobility to persons limited to a sitting position being transported either by an attendant or self-propelled.
This device is designed to be a typical manual wheelchair for use in an aquatic center setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031910: Stainless Steel Aquatic Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031910
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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