510(k) · Cleared
ClearedLandlex Model S400X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cycling and Health Tech. Industry R&D Center · INI Vehicle, Motorized 3-Wheeled
Cleared on Jul 7, 2005 as substantially equivalent to K043326 (Cycling and Health Tech. Industry R&D Center, 2005) after a 101-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it.
- Decided
- Jul 7, 2005
- Review
- 101 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013763 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK013763 Wu's 4-Wheeled Neo Scooter, WT-L4Wu'S Tech Co., Ltd. · 2002
- 2 generations backK033239 BE-Mobile 4-Wheeled Electric Scooter, Model DK S500Tung Keng Enterprise Co., Ltd. · 2003
- 1 generation backK043326 Bewell, Model SC 20Cycling and Health Tech. Industry R&D Center · 2005
- This deviceK050793 Landlex Model S400XCycling and Health Tech. Industry R&D Center · 2005
- Descendant · cites it directly · 0 of its ownK062646 Ruike, Model 3411Shanghai Ruike Sports Goods Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK063196 Landlex, Model S403XBesteam Technology, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013763 | Wu's 4-Wheeled Neo Scooter, WT-L4 | Wu'S Tech Co., Ltd. | 2002 | — |
| −2 | K033239 | BE-Mobile 4-Wheeled Electric Scooter, Model DK S500 | Tung Keng Enterprise Co., Ltd. | 2003 | — |
| −1 | K043326 | Bewell, Model SC 20 | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| 0 (this device) | K050793 | Landlex Model S400X | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +1 | K062646 | Ruike, Model 3411 | Shanghai Ruike Sports Goods Co., Ltd. | 2007 | — |
| +1 | K063196 | Landlex, Model S403X | Besteam Technology, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043326 | Bewell, Model SC 20Summary page 1…Product Code: 89IN1 Classification: Class 11 Predicate devices Manufacture name: Cycling and Health Tech Industry R&D Center/CHC Name: Bewell SC 20 k number: K043326 Date cleared: 0 1/26/2005 Intend use of device LANDLEX S400X scooter is intended for an indoor/outdoor scooter that provides… | 2005 |
What descends from it? (2)
2 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 3 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062646 (Shanghai Ruike Sports Goods Co., Ltd., 2007) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K043326.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 LANDLEX S400X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050793: Landlex Model S400X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050793
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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