# Koru Medical Systems, Inc.

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 2 (2023–2026): 2 510(k) clearances
- Names in FDA's records: Koru Medical Systems, Inc. (1); Koru Medical Systems (1)
- Product codes: FRN (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- Repro-Medical System, Inc., Dba Koru Medical Systems: 1 (https://510kreport.com/company/repro-medical-system-dba-koru-medical-systems)
- Repro-Med Systems, Inc. Dba Koru Medical Systems: 1 (https://510kreport.com/company/repro-med-systems-dba-koru-medical-systems)

## Recent decisions
- K252015: FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (Jan 28, 2026)
- K231918: Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter (Nov 3, 2023)

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