Koru Medical Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingJanuary 28, 2026
K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo SupNovember 3, 2023