510(k) · Cleared
ClearedAvanticare, Model SA4022
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lerado China Limited · INI Vehicle, Motorized 3-Wheeled
Cleared on Jul 21, 2005 as substantially equivalent to K043326 (Cycling and Health Tech. Industry R&D Center, 2005) after a 41-day review. Its family tree reaches back 3 generations to 2002. 12 later devices descend from it.
- Decided
- Jul 21, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013763 (2002). 12 later devices descend from it, 8 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 deviceK051538 Avanticare, Model SA4022Lerado China Limited · 2005
- Descendant · cites it directly · 9 of its ownK072630 Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK130940 Kymco EQ20C ScooterKwang Yang Motor Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK082901 Kymco Foru, Model EQ20Kwang Yang Motor Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK171256 Quingo Flyte Mobility ScooterAgile Distributors, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK163201 KYMCO EQ10D ScooterKwang Yang Motor Co., Ltd. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072630Foru, Model EQ30Kwang Yang Motor Co., Ltd. · 2007 · cites it directly9descendants
- K130940Kymco EQ20C ScooterKwang Yang Motor Co., Ltd. · 2013 · 2 generations on1descendant
- K082901Kymco Foru, Model EQ20Kwang Yang Motor Co., Ltd. · 2008 · cites it directly1descendant
- K171256Quingo Flyte Mobility ScooterAgile Distributors, LLC · 2017 · 2 generations on0descendants
- K163201KYMCO EQ10D ScooterKwang Yang Motor Co., Ltd. · 2017 · 3 generations on0descendants
View 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) | K051538 | Avanticare, Model SA4022 | Lerado China Limited | 2005 | — |
| +1 | K072630 | Foru, Model EQ30 | Kwang Yang Motor Co., Ltd. | 2007 | — |
| +2 | K130940 | Kymco EQ20C Scooter | Kwang Yang Motor Co., Ltd. | 2013 | — |
| +1 | K082901 | Kymco Foru, Model EQ20 | Kwang Yang Motor Co., Ltd. | 2008 | — |
| +2 | K171256 | Quingo Flyte Mobility Scooter | Agile Distributors, LLC | 2017 | — |
| +3 | K163201 | KYMCO EQ10D Scooter | Kwang Yang Motor Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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…el): Physical Medicine Device Regulation number. 590.3800 Product Code: 89INI Classification: Class II Predicate devices Bewell SC 20 (K043326)/Cyding and Health Tech Industry R&D Center/CHC Intend use of device AVAN'TICARE SA4022 scooter is intended for an ind… | 2005 |
What descends from it? (12)
See all 128 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 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072630 (Kwang Yang Motor Co., Ltd., 2007) has gone furthest, with 9 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 AVA&NTICARE SA4022 scooter is motor driven, indoor and outdoor transportation vehicles with the int-ndcd use to provide robility to disabled or elderly persons limited to a seated po ition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051538: Avanticare, Model SA4022.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051538
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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