FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is an FDA 510(k)-cleared medical device (K252015) manufactured by Koru Medical Systems, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 2026. Regulation: 8.