Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meticuly Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026-07-25 | 302 | 0 |
| K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 2026-01-14 | 120 | 0 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implan | Meticuly Co., Ltd. | 2024-04-30 | 225 | 0 |
| K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021-12-21 | 341 | 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