# Gainor Medical Europe, Ltd.

- Location (FDA's records): Mcdonough, GA
- FDA decisions: 13 (1990–1994): 13 510(k) clearances
- Product codes: FMK (3), FPA (2), KOC (1), FIE (1), KGX (1), FJK (1), KNX (1), KDH (1), FMI (1), CAT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Nipro Medical Corporation: 2 (https://510kreport.com/company/nipro-medical)
- Micropoint Technologies Pte, Ltd.: 1 (https://510kreport.com/company/micropoint-technologies)

## Its most-cited devices
- K926448: I.V. Administration Set (1994), cited by 2
- K931827: Cleanlet, Cleanlet XL & Kids (1993), cited by 1

## Recent decisions
- K926448: I.V. Administration Set (May 2, 1994)
- K931828: Carelet Safety Lancet (Oct 15, 1993)
- K931827: Cleanlet, Cleanlet XL & Kids (Sep 13, 1993)
- K922441: Sureseal Bandage (Aug 10, 1993)
- K913333: I.V. Priming Set (Oct 23, 1991)
- K902422: Needle, Aspiration & Injection, Disposable (Jun 6, 1991)
- K902420: Catheter, Nasal, Oxygen (Apr 17, 1991)
- K902564: Needle, Dialysis (Mar 1, 1991)

Source page: https://510kreport.com/company/gainor-medical-europe