510(k) · Cleared
ClearedScooter (Model: FDB01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Jun 25, 2021 as substantially equivalent to K182471 (Tianjin Kepler Vehicle Industry Co., Ltd., 2019) and 1 other predicate after a 417-day review. Its family tree reaches back 7 generations to 1992. 7 later devices descend from it.
- Decided
- Jun 25, 2021
- Review
- 417 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K923193 (1992). 10 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- 6 generations backK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- 5 generations backK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- 4 generations backK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- 3 generations backK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- 2 generations backK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
- 1 generation backK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- This deviceK201196 Scooter (Model: FDB01)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK242982 Mobility Scooter (MS160A)Suzhou Master Machinery Manufacturing Co.,Ltd · 2025
- Descendant · cites it directly · 1 of its ownK242387 Mobility Scooter (N3473)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2024
- Descendant · 2 generations on · 0 of its ownK261859 Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252275 Electric Scooter (DDF100)Zhejiang Nysin Medical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242975 Mobility Scooter (Model X-01, X-02)Wuyi Aichi Industry & Trade Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K242982Mobility Scooter (MS160A)Suzhou Master Machinery Manufacturing Co.,Ltd · 2025 · cites it directly1descendant
- K242387Mobility Scooter (N3473)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2024 · cites it directly1descendant
- K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd. · 2026 · 2 generations on0descendants
- K252275Electric Scooter (DDF100)Zhejiang Nysin Medical Co., Ltd. · 2026 · cites it directly0descendants
- K242975Mobility Scooter (Model X-01, X-02)Wuyi Aichi Industry & Trade Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| −6 | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| −5 | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −4 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −3 | K070603 | C.T.M. Mobilitty Scooter # HS-295 | C.T.M. Homecare Product, Inc. | 2007 | — |
| −2 | K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017 | — |
| −1 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| 0 (this device) | K201196 | Scooter (Model: FDB01) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2021 | — |
| +1 | K242982 | Mobility Scooter (MS160A) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025 | — |
| +1 | K242387 | Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024 | — |
| +2 | K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | 2026 | — |
| +1 | K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | 2026 | — |
| +1 | K242975 | Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K182471 | ScooterSummary page 4…vice (Primary): Sponsor TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD. Device Name Scooter (KPL001) 510Knumber K182471 2nd Predicate device Sponsor Dongguan Prestige Sporting Goods Co., Ltd Device Name… | 2019 |
| * | K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151Summary page 4…e device Sponsor Dongguan Prestige Sporting Goods Co., Ltd Device Name Solax Electric Scooter 510Knumber K172440 D. Indications for use It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobilit… | 2018 |
What descends from it? (7)
6 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 29 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K242982 (Suzhou Master Machinery Manufacturing Co.,Ltd, 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K182471.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201196: Scooter (Model: FDB01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201196
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