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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252015

510(k) cleared

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

Koru Medical Systems, Inc. · Jan 28, 2026 · K252015

FDA cleared the FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing from Koru Medical Systems, Inc. on Jan 28, 2026 under K252015, a traditional 510(k). The device falls under product code FRN, Pump, Infusion, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 27, 2025. The decision came 215 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Koru Medical Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252015?

K252015 is the FDA 510(k) for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing, submitted by Koru Medical Systems, Inc.. FDA's decision date was Jan 28, 2026, under product code FRN (Pump, Infusion).

Who makes the FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

Koru Medical Systems, Inc., based in Mahwah, NJ, is the applicant of record for K252015.

How long did the K252015 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Jan 28, 2026, 215 days later.

← All decisions in January 2026