Cleared Traditional

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

K252015 · Koru Medical Systems, Inc. · General Hospital

Jan 2026

Decision

215d

Days

Class 2

Risk

About This 510(k) Submission

K252015 is an FDA 510(k) clearance for the FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Koru Medical Systems, Inc. (Mahwah, US). The FDA issued a Cleared decision on January 28, 2026, 215 days after receiving the submission on June 27, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K252015 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2025
Decision Date	January 28, 2026
Days to Decision	215 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF