510(k) Report

510(k) · Cleared

Recalled · Class II · 2011

Victory Three Wheel Scooter, Model: SC610

K072165510(k) SpecialCleared Aug 17, 200711-day reviewClass II21 CFR 890.3800Recalls 2

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

Pride Mobility Products Corp. · INI Vehicle, Motorized 3-Wheeled

Cleared on Aug 17, 2007 as substantially equivalent to K926295 (Pride Health Care, Inc., 1994) after an 11-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled 2 times.

Decided
Aug 17, 2007
Review
11 days
Class
Class II
Product code
INI
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K926295 (1994). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2009: 1 descendant clearedK926295 · Legend SC 300 · Pride Health Care, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 2 descendants K926295 · Legend SC 300 · Pride Health Care, Inc. · 19940
  1. Root · 1 generation backK926295 Legend SC 300Pride Health Care, Inc. · 1994
  2. This deviceK072165 Victory Three Wheel Scooter, Model: SC610Pride Mobility Products Corp. · 2007
  3. Descendant · cites it directly · 0 of its ownK110567 C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc. · 2011
  4. Descendant · cites it directly · 0 of its ownK090805 V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter…Pride Mobility Products Corp. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K110567C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc. · 2011 · cites it directly0descendants
  • K090805V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10…Pride Mobility Products Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926295Legend SC 300Pride Health Care, Inc.1994—
0 (this device)K072165Victory Three Wheel Scooter, Model: SC610Pride Mobility Products Corp.2007—
+1K110567C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc.2011—
+1K090805V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model…Pride Mobility Products Corp.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
FIG. 1 — Lineage of K072165, 1994–2011Source: 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.

Planning a device in INI? 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 INI device

  1. #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K926295Legend SC 300
Summary page 1
…ee - Wheeled Vehicle Product Code: INI Comparison to Predicate Devices: The Victory Three Wheel Scooter is substantially equivalent to the Pride Mobility Legend SC300 (K926295) when comparing components, performance, maneuverability, stability, and structure. The performance characteristics and the posit…
Pride Health Care, Inc.1994—

Also cleared against K926295: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110567C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc.20110
K090805V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10…Pride Mobility Products Corp.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 22, 2011Not classifiedZ-3211-2011Nonconforming Material/ComponentContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
Nov 26, 2010Class IIZ-1941-2012Nonconforming Material/ComponentThe main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through the nonconforming harness.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K110567 (C.T.M. Homecare Product, Inc., 2011) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K926295.

How does its category compare?

All INI devices

INI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · INI

21so far in 2026, the most since 2007

2007: 182008: 72009: 122010: 52011: 52012: 12013: 22014: 12015: 92016: 12017: 52018: 32019: 42020: 12021: 52022: 62023: 92024: 82025: 152026 (partial year): 21
2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007: 29 days median2008: 28 days median2009: 41 days median2010: 46 days median2011: 130 days median2015: 202 days median2017: 191 days median2018: 266 days median2019: 298 days median2021: 575 days median2022: 159 days median2023: 123 days median2024: 137 days median2025: 111 days median2026 (partial year): 108 days median
2007high 575 (2021) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · INI

1in 2013

2007: 22010: 32011: 32013: 1
2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INI

26in 2025

2007: 642008: 292009: 252010: 562011: 702012: 1722013: 4542014: 5672015: 1512016: 762017: 452018: 512019: 252020: 262021: 412022: 412023: 322024: 312025: 26
2007high 567 (2014) · low 25 (2009)2025

MAUDE reports naming product code INI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071829264
2008728029
20091241025
2010546356
20115130370
20121—0172
20132—1454
20141—0567
201592020151
20161—076
20175191045
20183266051
20194298025
20201—026
20215575041
20226159041
20239123032
20248137031
202515111026
2026211080—

What is it indicated for?

The intended use of the Pride Mobility Products Corporation Victory Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072165: Victory Three Wheel Scooter, Model: SC610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072165

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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