510(k) · Cleared
ClearedLandlex, Model S300X
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 Apr 21, 2005 as substantially equivalent to K033241 (Tung Keng Enterprise Co., Ltd., 2003) after a 24-day review. Its family tree reaches back 2 generations to 2002. 4 later devices descend from it.
- Decided
- Apr 21, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023010 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK023010 Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002
- 1 generation backK033241 BE-Mobile 3-Wheeled Electric Scooter, Model DK S320Tung Keng Enterprise Co., Ltd. · 2003
- This deviceK050792 Landlex, Model S300XCycling and Health Tech. Industry R&D Center · 2005
- Descendant · cites it directly · 3 of its ownK052378 Proasia, Model L3402Proasia Limited · 2005
- Descendant · cites it directly · 2 of its ownK060042 Landlex, Model P100XBesteam Technology, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK062676 Ruike, Model 3331Shanghai Ruike Sports Goods Co., Ltd. · 2006
- Descendant · 3 generations on · 0 of its ownK102358 ZIP'R3/ ZIP'R3 Xtra ScooterGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2010
Most influential descendants
Showing 4 of 4 · See all- K052378Proasia, Model L3402Proasia Limited · 2005 · cites it directly3descendants
- K060042Landlex, Model P100XBesteam Technology, Inc. · 2006 · cites it directly2descendants
- K062676Ruike, Model 3331Shanghai Ruike Sports Goods Co., Ltd. · 2006 · 2 generations on1descendant
- K102358ZIP'R3/ ZIP'R3 Xtra ScooterGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023010 | Sniff Position Pillows/Popitz Pillows | Aeolus International Corporation | 2002 | — |
| −1 | K033241 | BE-Mobile 3-Wheeled Electric Scooter, Model DK S320 | Tung Keng Enterprise Co., Ltd. | 2003 | — |
| 0 (this device) | K050792 | Landlex, Model S300X | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| +1 | K052378 | Proasia, Model L3402 | Proasia Limited | 2005 | — |
| +1 | K060042 | Landlex, Model P100X | Besteam Technology, Inc. | 2006 | — |
| +2 | K062676 | Ruike, Model 3331 | Shanghai Ruike Sports Goods Co., Ltd. | 2006 | — |
| +3 | K102358 | ZIP'R3/ ZIP'R3 Xtra Scooter | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K033241 | BE-Mobile 3-Wheeled Electric Scooter, Model DK S320Summary page 1…891NI Classification: Class II Predicate devices Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 3-Wheeled Electric Scooter, DK S320 k number: K033241 Date cleared: 11/10/2003 Intend use of device LANDLEX S300X scooter is intended for an indoor/outdoor scooter that provides… | 2003 |
What descends from it? (4)
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 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K052378 (Proasia Limited, 2005) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K033241.
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 S300X 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/K050792 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050792: Landlex, Model S300X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050792
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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