510(k) K252015

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing by Koru Medical Systems, Inc. — Product Code FRN

K252015 is an FDA 510(k) premarket notification submitted by Koru Medical Systems, Inc. for the device "FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing". The FDA issued a decision of Substantially Equivalent on January 28, 2026. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Koru Medical Systems, Inc. has at least 1 other 510(k) clearance on record.