Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Filmec Co. , Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232574 | VASSALLO GT Crossing14 | Filmec Co. , Ltd. | 2023-10-11 | 47 | 0 |
| K232578 | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | Filmec Co. , Ltd. | 2023-10-11 | 47 | 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