Foshan Coxo Medical Instrument Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Foshan Coxo Medical Instrument Co., Ltd.” (first 2022, latest 2025), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 261 days. Since 2017 the median was 261 days, against 246 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 3 | 261 |
| 2023 | 3 | 422 |
| 2024 | 0 | — |
| 2025 | 1 | 112 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Foshan Coxo Medical Instrument Co., Ltd. took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 246 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| LQY | Locator, Root Apex | 1 | 1 |
Review panels
- Dental (7)
Most recent Foshan Coxo Medical Instrument Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243921 | LED Curing Lights (DB686 HALO) | EBZ | 2025-04-11 | 112 |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | EFB | 2023-09-22 | 609 |
| K220829 | Endo Motor | EKX | 2023-05-18 | 422 |
| K222096 | Endo Ultrasonic Activator | ELC | 2023-03-23 | 248 |
| K220826 | LED Curing Light | EBZ | 2022-12-08 | 261 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | EBW | 2022-09-27 | 189 |
| K212178 | Root Apex Locator | LQY | 2022-07-20 | 373 |
Recalls
openFDA lists no recalls under a recalling firm named Foshan Coxo Medical Instrument Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Foshan Nanhai Plus Medical Co, Ltd. (8 510(k)s)
- Foshan Gaunying Electronics Co., Ltd. (6 510(k)s)
- Foshan Care Medical Technology Co., Ltd. (4 510(k)s)
- Foshan Cicada Dental Instrument Co, Ltd. (4 510(k)s)
- Foshan Dahao Medical Technology Co., Ltd. (3 510(k)s)
- Foshan Pingchuang Medical Technology Co., Ltd. (3 510(k)s)
- Foshan United Medical Technologies, Ltd. (3 510(k)s)
- Foshan Hongfeng Co., Ltd. (2 510(k)s)
- Foshan Jindi Electric Appliance Co., Ltd. (2 510(k)s)
- Foshan Kycare Medical Equipment Co., Ltd. (2 510(k)s)
- Foshan Nanhai Bai HE Medical Technology Co., Ltd. (2 510(k)s)
- Foshan Topmed Dental Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Foshan Coxo Medical Instrument Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Foshan Coxo Medical Instrument Co., Ltd.” (first 2022, latest 2025), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Foshan Coxo Medical Instrument Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Foshan Coxo Medical Instrument Co., Ltd. is 261 days. Since 2017: 261 days, versus 246 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Foshan Coxo Medical Instrument Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 2); EBW (Controller, Foot, Handpiece And Cord, 1); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 7 Foshan Coxo Medical Instrument Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Foshan Coxo Medical Instrument Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.