# Filmecc Co., Ltd.

- Location (FDA's records): Hagoya-Shi, JP
- FDA decisions: 6 (2021–2026): 6 510(k) clearances
- Product codes: DQX (6)
- 510(k) review time since 2016: median 140 days, against 161 for FDA's reviews in the same codes and years (6 of 6 faster)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asahi Intecc Co., Ltd.: 6 (https://510kreport.com/company/asahi-intecc)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Ashitaka Factory of Terumo Corp.: 1 (https://510kreport.com/company/ashitaka-factory-of-terumo)

## Firms that cite its devices most
- Filmec Co., Ltd.: 2 (https://510kreport.com/company/filmec)

## Its most-cited devices
- K203533: Vassallo GT (2021), cited by 3
- K203529: VASSALLO GT Hybrid (2021), cited by 1

## Recent decisions
- K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (Sep 3, 2026)
- K223432: Vassallo GT 018 Hybrid (Mar 9, 2023)
- K222631: Vassallo GT Ext (Oct 26, 2022)
- K213949: VASSALLO GT 018 Floppy (Jun 30, 2022)
- K203529: VASSALLO GT Hybrid (May 4, 2021)
- K203533: Vassallo GT (Apr 21, 2021)

Source page: https://510kreport.com/company/filmecc