510(k) Report

510(k) · Cleared

Cleared

Hippocampe Marathon and Trail

K251570510(k) TraditionalCleared Jun 23, 202532-day reviewClass II21 CFR 890.3880

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vipamat Sarl · IQC Wheelchair, Special Grade

Cleared on Jun 23, 2025 as substantially equivalent to K051709 (Vipamat Technologie, 2005) after a 32-day review. Its family tree reaches back 4 generations to 1992.

Decided
Jun 23, 2025
Review
32 days
Class
Class II
Product code
IQC
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K915262 (1992). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor K051709 · Hippocampe Wheelchair · Vipamat Technologie · 2005K031910 · Stainless Steel Aquatic Wheelchair · Db Perks & Associates, Ltd. · 2003K982607 · Manual Wheelchair · G. Hirsch and Co., Inc. · 1998K915262 · Bantex Brand Wheelchairs · Bantex Corp. · 19920
  1. Root · 4 generations backK915262 Bantex Brand WheelchairsBantex Corp. · 1992
  2. 3 generations backK982607 Manual WheelchairG. Hirsch and Co., Inc. · 1998
  3. 2 generations backK031910 Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003
  4. 1 generation backK051709 Hippocampe WheelchairVipamat Technologie · 2005
  5. This deviceK251570 Hippocampe Marathon and TrailVipamat Sarl · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K915262Bantex Brand WheelchairsBantex Corp.1992—
−3K982607Manual WheelchairG. Hirsch and Co., Inc.1998—
−2K031910Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd.2003—
−1K051709Hippocampe WheelchairVipamat Technologie2005—
0 (this device)K251570Hippocampe Marathon and TrailVipamat Sarl2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
200310
FIG. 1 — Lineage of K251570, 1992–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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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.

TypeNumberDeviceApplicantDecidedRecalls
*K051709Hippocampe Wheelchair
Summary page 5
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K051709 Hippocampe Wheelchair IQC Device Descript…
Vipamat Technologie2005—

Also cleared against K051709: 1 other device →

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 33 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
  • None of the 7 ancestors has a recall.
  • 1 other device also cites its predicate K051709.

How does its category compare?

All IQC devices

IQC Wheelchair, Special Grade: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · IQC

1in 2025

2009: 12012: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IQC

Too few IQC 510(k)s in any year since 2007 to give a median.

Recalls per year · IQC

No recall names IQC since 2007.

Adverse event reports per year · IQC

No MAUDE report names IQC since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20260—0—

What is it indicated for?

The Hippocampe Marathon and Trail is indicated to provide mobility to persons restricted to a seated position on various terrains, including footpaths and trails.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K251570: Hippocampe Marathon and Trail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251570

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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