Golden Technologies, Inc.: FDA clearances and approvals
Golden Technologies, Inc. has 8 FDA 510(k) clearances (first 1988, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time: 29 days. openFDA lists 2 product recalls by a recalling firm named Golden Technologies, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 5 | 5 |
| ITI | Wheelchair, Powered | 2 | 2 |
| INO | Chair, Positioning, Electric | 1 | 1 |
Review panels
Most recent Golden Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063162 | GOLDEN LITEWAY | INI | 2006-11-02 | 15 |
| K041341 | GOLDEN SPYDER, MODEL GS-300 | ITI | 2004-06-03 | 14 |
| K041025 | BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED | INI | 2004-05-03 | 12 |
| K012258 | COMPANION MODEL 221, 321, 421 | INI | 2001-12-03 | 138 |
| K011153 | ALANTE, BATTERY OPERATED POWER WHEELCHAIR | ITI | 2001-05-29 | 43 |
| K971050 | GOLDEN HAWK | INI | 1997-08-01 | 133 |
| K971043 | GOLDEN EAGLE | INI | 1997-08-01 | 133 |
| K880800 | GOLDEN POWER LIFT CHAIR | INO | 1988-03-14 | 14 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-07-06.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Golden Technologies, Inc. have?
Golden Technologies, Inc. has 8 FDA 510(k) clearances (first 1988, latest 2006), across 3 product codes in 1 review panel.
How long does FDA take to clear Golden Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Golden Technologies, Inc.'s cleared 510(k)s is 29 days.
What devices does Golden Technologies, Inc. make?
Its most frequent FDA product codes are INI (Vehicle, Motorized 3-Wheeled, 5); ITI (Wheelchair, Powered, 2); INO (Chair, Positioning, Electric, 1).
Has Golden Technologies, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Golden Technologies, Inc; the most recent began 2020-07-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Golden Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, Golden Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.