510(k) · Cleared
ClearedV10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10, Four Wheel Scooter, Model SC710
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pride Mobility Products Corp. · INI Vehicle, Motorized 3-Wheeled
Cleared on Apr 3, 2009 as substantially equivalent to K072165 (Pride Mobility Products Corp., 2007) and 1 other predicate after a 9-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Apr 3, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930952 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK930952 Pride Legend SC-340Pride Health Care, Inc. · 1994
- 1 generation backK071949 Victory, 4 Wheel Scooter / Model, # SC1740Pride Mobility Products Corp. · 2007 · Recalled
- This deviceK090805 V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter…Pride Mobility Products Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930952 | Pride Legend SC-340 | Pride Health Care, Inc. | 1994 | — |
| −1 | K071949 | Victory, 4 Wheel Scooter / Model, # SC1740 | Pride Mobility Products Corp. | 2007 | 1 |
| 0 (this device) | K090805 | V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model… | Pride Mobility Products Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2007 | 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 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 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 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 |
|---|---|---|---|
| * | K072165 | Victory Three Wheel Scooter, Model: SC610Summary page 1…eeled Vehicle Product Code: INI Comparison to Predicate Devices: The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) when comparing, performance, maneuverability, stability, and structure. The perform… | 2007 |
| * | K071949 | Victory, 4 Wheel Scooter / Model, # SC1740Summary page 1…to Predicate Devices: The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) when comparing, performance, maneuverability, stability, and structure. The performance characteristics and the position of the… | 2007 |
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 15 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K072165.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · INI
21so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 2025
MAUDE reports naming product code INI, 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 | 18 | 29 | 2 | 64 |
| 2008 | 7 | 28 | 0 | 29 |
| 2009 | 12 | 41 | 0 | 25 |
| 2010 | 5 | 46 | 3 | 56 |
| 2011 | 5 | 130 | 3 | 70 |
| 2012 | 1 | — | 0 | 172 |
| 2013 | 2 | — | 1 | 454 |
| 2014 | 1 | — | 0 | 567 |
| 2015 | 9 | 202 | 0 | 151 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 5 | 191 | 0 | 45 |
| 2018 | 3 | 266 | 0 | 51 |
| 2019 | 4 | 298 | 0 | 25 |
| 2020 | 1 | — | 0 | 26 |
| 2021 | 5 | 575 | 0 | 41 |
| 2022 | 6 | 159 | 0 | 41 |
| 2023 | 9 | 123 | 0 | 32 |
| 2024 | 8 | 137 | 0 | 31 |
| 2025 | 15 | 111 | 0 | 26 |
| 2026 | 21 | 108 | 0 | — |
What is it indicated for?
The intended use of the Pride Mobility Products Corporation V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090805: V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10, Four Wheel Scooter, Model SC710.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090805
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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