# Repro-Medical System, Inc., Dba Koru Medical Systems

- Location (FDA's records): New York, NY
- FDA decisions: 2 (2021–2022): 2 510(k) clearances
- Product codes: FRN (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (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
- Repro-Med Systems, Inc. Dba Rms Medical Products: 1 (https://510kreport.com/company/repro-med-systems-dba-rms-medical-products)

## Firms that cite its devices most
- Koru Medical Systems, Inc.: 1 (https://510kreport.com/company/koru-medical-systems)

## Its most-cited devices
- K211206: FreedomEdge (R) Syringe Infusion System (2021), cited by 1
- K214045: FreedomEdge Syringe Infusion System (2022), cited by 1

## Recent decisions
- K214045: FreedomEdge Syringe Infusion System (Apr 29, 2022)
- K211206: FreedomEdge (R) Syringe Infusion System (Nov 9, 2021)

Source page: https://510kreport.com/company/repro-medical-system-dba-koru-medical-systems