Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shinchang 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) |
|---|---|---|---|---|---|
| K071382 | SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4 | Shinchang Medical Co., Ltd. | 2007-10-16 | 152 | 0 |
| K070988 | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G | Shinchang Medical Co., Ltd. | 2007-08-23 | 139 | 0 |
| K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT I | Shinchang Medical Co., Ltd. | 2000-02-25 | 170 | 6 |
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