Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Filmecc Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
195 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223432 | Vassallo GT 018 Hybrid | Filmecc Co., Ltd. | 2023-03-09 | 115 | 0 |
| K222631 | VASSALLO GT EXT | Filmecc Co., Ltd. | 2022-10-26 | 56 | 0 |
| K213949 | VASSALLO GT 018 Floppy | Filmecc Co., Ltd. | 2022-06-30 | 195 | 0 |
| K203529 | VASSALLO GT Hybrid | Filmecc Co., Ltd. | 2021-05-04 | 153 | 0 |
| K203533 | VASSALLO GT | Filmecc Co., Ltd. | 2021-04-21 | 140 | 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