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Koru Medical Systems

FDA Regulatory Profile

Koru Medical Systems appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 28, 2026.

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

FDA data resources