# Fuji Systems Corp.

- Location (FDA's records): Mccordsville, IN
- FDA decisions: 3 (2005–2022): 3 510(k) clearances
- Names in FDA's records: Fuji Systems Corp. (2); Fuji Systems Corporation (1)
- Product codes: CBI (1), QJP (1), DQY (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 6 (1 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
- Mallinckrodt Critical Care: 1 (https://510kreport.com/company/mallinckrodt-critical-care)
- Vitaid, Ltd.: 1 (https://510kreport.com/company/vitaid)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)

## Firms that cite its devices most
- Etview, Ltd.: 1 (https://510kreport.com/company/etview)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)
- Hytek Medical, Inc.: 1 (https://510kreport.com/company/hytek-medical)
- Well Lead Instruments: 1 (https://510kreport.com/company/well-lead-instruments)
- Teleflexmedical, Inc.: 1 (https://510kreport.com/company/teleflexmedical)

## Its most-cited devices
- K051522: Silbroncho Double Lumen Tube (2005), cited by 4
- K120781: Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length (2012), cited by 2

## Recent decisions
- K223275: CELLO II Balloon Guide Catheter (Dec 9, 2022)
- K120781: Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length (Aug 9, 2012)
- K051522: Silbroncho Double Lumen Tube (Aug 17, 2005)

Source page: https://510kreport.com/company/fuji-systems