# Terumo America, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 31 (1976–1981): 31 510(k) clearances
- Product codes: FJI (5), FMI (3), FIE (2), FPA (2), KDJ (1), FPB (1), GAA (1), KOC (1), GKT (1), KNY (1), FKJ (1), FLL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 19 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Terumo Medical Corp.: 8 (https://510kreport.com/company/terumo-medical)
- Bioteque Corp.: 1 (https://510kreport.com/company/bioteque)
- Terumo Europe N.V.: 1 (https://510kreport.com/company/terumo-europe)
- Gettig Pharmaceutical Instrument Co.: 1 (https://510kreport.com/company/gettig-pharmaceutical-instrument)
- Duopross Meditech Corporation: 1 (https://510kreport.com/company/duopross-meditech)
- Innovative Medical Manufacturing Co.: 1 (https://510kreport.com/company/innovative-medical-manufacturing)
- Bioject Medical Technologies, Inc.: 1 (https://510kreport.com/company/bioject-medical-technologies)
- Ferguson Medical: 1 (https://510kreport.com/company/ferguson-medical)

## Its most-cited devices
- K771203: Disp. Hypodermic Needle (1977), cited by 8
- K771205: Hypodermic Syringe (1977), cited by 6
- K771204: Surflo Winged Infusion Set (1977), cited by 3
- K760775: Terumo Disposable Spinal Needle (1976), cited by 1
- K760948: Thermo Finer Coretemp (1976), cited by 1

## Recent decisions
- K811523: Plasma Flex (Sep 9, 1981)
- K802970: Terumo Hollow Fiber Oxygenator (Jan 22, 1981)
- K802441: Clirans TH10 Hollow Fiber Dialyzer (Dec 18, 1980)
- K802122: Clirans TH13 Hollow Fiber Dialyzer (Dec 18, 1980)
- K801193: Clirans TE15 Hollow Fiber Dialyzer (Aug 12, 1980)
- K801194: Clirans TE07 Hollow Fiber Dialyzer (Aug 12, 1980)
- K801192: Clirans TE10 Hollow Fiber Dialyzer (Aug 12, 1980)
- K791411: Coaxial Dual Flow Catheter (Nov 13, 1979)

Source page: https://510kreport.com/company/terumo-america