510(k) · Cleared
ClearedMaxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940V
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 May 11, 2009 as substantially equivalent to K926296 (Pride Health Care, Inc., 1994) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 11, 2009
- Review
- 24 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926296 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK926296 Celebrity SC400Pride Health Care, Inc. · 1994
- This deviceK091113 Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel…Pride Mobility Products Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926296 | Celebrity SC400 | Pride Health Care, Inc. | 1994 | — |
| 0 (this device) | K091113 | Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter… | Pride Mobility Products Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K926296 | Celebrity SC400Summary page 1…cle Product Code: INI Comparison to Predicate Devices: The Maxima V, Three and four Wheel Scooters are substantially equivalent to the Pride Mobility Sunrunner SC 400 (K926296), and Sunrunner SC440 (K930953) when comparing, performance, maneuverability, stability, and structure. The performance character… | 1994 |
| * | K930953 | Celebrity SC440Summary page 1…son to Predicate Devices: The Maxima V, Three and four Wheel Scooters are substantially equivalent to the Pride Mobility Sunrunner SC 400 (K926296), and Sunrunner SC440 (K930953) when comparing, performance, maneuverability, stability, and structure. The performance characteristics and the position of the… | 1994 |
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?
- None of the 2 ancestors has a recall.
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 Maxima V, Three and Four Wheel 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/K091113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091113: Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091113
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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