Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Incore Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
428 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | 2024-04-19 | 268 | 0 |
| K221054 | CORE-INJECTOR | Incore Co., Ltd. | 2022-12-21 | 254 | 0 |
| K220846 | CORE-SNARE | Incore Co., Ltd. | 2022-11-21 | 243 | 0 |
| K220081 | CORE-SPORT | Incore Co., Ltd. | 2022-09-28 | 261 | 0 |
| K213338 | CORE-CLIP | Incore Co., Ltd. | 2022-06-23 | 259 | 0 |
| K211148 | CORE-Trocar | Incore Co., Ltd. | 2022-06-21 | 428 | 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