510(k) · Cleared
ClearedScooter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Kepler Vehicle Industry Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Jul 10, 2019 as substantially equivalent to K172440 (Dongguan Prestige Sporting Goods., Ltd., 2018) and 1 other predicate after a 303-day review. Its family tree reaches back 6 generations to 1992. 34 later devices descend from it.
- Decided
- Jul 10, 2019
- Review
- 303 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K923193 (1992). 9 ancestors in all. 34 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- 5 generations backK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- 4 generations backK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- 3 generations backK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- 2 generations backK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- 1 generation backK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
- This deviceK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- Descendant · cites it directly · 19 of its ownK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- Descendant · 2 generations on · 12 of its ownK222507 Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · 3 generations on · 11 of its ownK231428 Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · cites it directly · 7 of its ownK201196 Scooter (Model: FDB01)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2021
- Descendant · 2 generations on · 5 of its ownK222495 Mobility Scooter, Model: W3331FZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K220206Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · cites it directly19descendants
- K222507Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 2 generations on12descendants
- K231428Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 3 generations on11descendants
- K201196Scooter (Model: FDB01)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2021 · cites it directly7descendants
- K222495Mobility Scooter, Model: W3331FZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| −5 | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| −4 | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −3 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −2 | K070603 | C.T.M. Mobilitty Scooter # HS-295 | C.T.M. Homecare Product, Inc. | 2007 | — |
| −1 | K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017 | — |
| 0 (this device) | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| +1 | K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| +2 | K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +3 | K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +1 | K201196 | Scooter (Model: FDB01) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2021 | — |
| +2 | K222495 | Mobility Scooter, Model: W3331F | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Summary page 6…2 510(k) Summary 6. Identification of Predicate Device Predicate #1 510(k) Number: K172440 Product Name: Solax Electric Scooter Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd. Predicate #2… | 2018 |
| * | K162952 | C.T.M. Mobility ScooterSummary page 6…510(k) Number: K172440 Product Name: Solax Electric Scooter Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd. Predicate #2 510(k) Number: K162952 Product Name: C.T.M. Mobility Scooter Manufacturer: Chien Ti Enterprise Co., Ltd. 7. Non-Clinical Test Conclusion… | 2017 |
What descends from it? (34)
See all 345 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 27 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K220206 (Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, 2022) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K172440.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182471: Scooter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182471
Report an extraction error
Are you the manufacturer?
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