Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangdong Jinme Medical Technology Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W40 | Guangdong Jinme Medical Technology Co., Ltd. | 2024-11-13 | 282 | 0 |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-07-18 | 164 | 0 |
| K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-21 | 300 | 0 |
| K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-08 | 287 | 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