Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Foshan Coxo Medical Instrument Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
609 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 | 112 | 0 |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared | Foshan Coxo Medical Instrument Co., Ltd. | 2023-09-22 | 609 | 0 |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 | 422 | 0 |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | 2023-03-23 | 248 | 0 |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 | 261 | 0 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022-09-27 | 189 | 0 |
| K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 | 373 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda