FDA applicant
Filmecc Co., Ltd.
FDA records 6 decisions for Filmecc Co., Ltd. (Hagoya-Shi, JP) from 2021 to 2026: 6 510(k) clearances. All are in product code DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 161 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Filmecc Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Filmecc Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report