Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mediclus Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
154 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261728 | One-Fil LC | Mediclus Co., Ltd. | 2026-07-21 | 56 | 0 |
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 | 90 | 0 |
| K260819 | Any-Com Seal | Mediclus Co., Ltd. | 2026-05-01 | 49 | 0 |
| K253797 | One-Stop | Mediclus Co., Ltd. | 2026-02-27 | 91 | 0 |
| K253167 | Any-Paste | Mediclus Co., Ltd. | 2026-01-12 | 108 | 0 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 | 121 | 0 |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025-08-22 | 63 | 0 |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 2025-06-06 | 42 | 0 |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | 2025-04-14 | 27 | 0 |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025-03-14 | 136 | 0 |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd. | 2025-02-07 | 151 | 0 |
| K241147 | Any-Com | Mediclus Co., Ltd. | 2024-09-26 | 154 | 0 |
| K232182 | One-Fil | Mediclus Co., Ltd. | 2024-01-26 | 186 | 0 |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023-05-22 | 90 | 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