# Kofu Factory of Terumo Corp.

- Location (FDA's records): Elkton, MD
- FDA decisions: 4 (2005–2014): 4 510(k) clearances
- Product codes: FMI (2), FOZ (2)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 4 (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
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Terumo Corp.: 2 (https://510kreport.com/company/terumo)
- Becton Dickinson Vascular Access, Inc.: 2 (https://510kreport.com/company/becton-dickinson-vascular-access)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)
- Htl-Strefa S.A: 1 (https://510kreport.com/company/htl-strefa-s-a)
- Daejin Tech Medical Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/daejin-tech-medical-manufacturing)

## Its most-cited devices
- K140516: Terumo Pen Injector Needle 34 (2014), cited by 2
- K052561: Terumo Micro Tapered Pen Needle (2005), cited by 2

## Recent decisions
- K140516: Terumo Pen Injector Needle 34 (Aug 5, 2014)
- K141138: Surflash Safety I.V. Catheter (May 30, 2014)
- K123267: Surfflash (R) Plus Safety I.V. Catheter (Nov 2, 2012)
- K052561: Terumo Micro Tapered Pen Needle (Nov 23, 2005)

Source page: https://510kreport.com/company/kofu-factory-of-terumo