Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canwell Medical Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | 2025-04-24 | 210 | 0 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 | 149 | 0 |
| K142943 | Metallic Locking Bone Plate and Screw | Canwell Medical Co., Ltd. | 2015-08-03 | 297 | 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