Filmecc Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Filmecc Co., Ltd.” (first 2021, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 140 days. Since 2017 the median was 140 days, against 134 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 146 |
| 2022 | 2 | 126 |
| 2023 | 1 | 115 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 139 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Filmecc Co., Ltd. took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Filmecc Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | DQX | 2026-09-03 | 139 |
| K223432 | Vassallo GT 018 Hybrid | DQX | 2023-03-09 | 115 |
| K222631 | VASSALLO GT EXT | DQX | 2022-10-26 | 56 |
| K213949 | VASSALLO GT 018 Floppy | DQX | 2022-06-30 | 195 |
| K203529 | VASSALLO GT Hybrid | DQX | 2021-05-04 | 153 |
| K203533 | VASSALLO GT | DQX | 2021-04-21 | 140 |
Recalls
openFDA lists no recalls under a recalling firm named Filmecc Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Filmecc Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Filmecc Co., Ltd.” (first 2021, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Filmecc Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Filmecc Co., Ltd. is 140 days. Since 2017: 140 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Filmecc Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 6).
Next steps
- See all 6 Filmecc Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Filmecc Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.