510(k) · Cleared
ClearedCompanion Model 221, 321, 421
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Technologies, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on Dec 3, 2001 after a 138-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Dec 3, 2001
- Review
- 138 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK012258 Companion Model 221, 321, 421Golden Technologies, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK041025 Buzzaround, Vehicle, Motorized 3-WheeledGolden Technologies, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK063162 Golden LitewayGolden Technologies, Inc. · 2006
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 |
|---|---|---|---|---|---|
| 0 (this device) | K012258 | Companion Model 221, 321, 421 | Golden Technologies, Inc. | 2001 | — |
| +1 | K041025 | Buzzaround, Vehicle, Motorized 3-Wheeled | Golden Technologies, Inc. | 2004 | 1 |
| +2 | K063162 | Golden Liteway | Golden Technologies, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041025 | Buzzaround, Vehicle, Motorized 3-Wheeled | 2004 | 1 |
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?
- Of its descendants, K041025 (Golden Technologies, Inc., 2004) has gone furthest, with 1 descendant of its own.
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 device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera. The device is intended to…
Read the full statement (216 words)
The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.
The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.
The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or 1mpa1rment severe back impairment, paralysis, et cetera.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012258: Companion Model 221, 321, 421.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012258
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026