Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicore 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) |
|---|---|---|---|---|---|
| K212412 | IRIS-XP | Medicore Co., Ltd. | 2021-09-13 | 41 | 0 |
| K110374 | MAX PULSE SYSTEM | Medicore Co., Ltd. | 2011-06-13 | 124 | 0 |
| K073323 | SA-3000P | Medicore Co., Ltd. | 2007-11-29 | 2 | 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