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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 / July 2026 / K260539

510(k) cleared

MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter

MedSource Labs, LLC · Jul 9, 2026 · K260539

FDA cleared the MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter from MedSource Labs, LLC on Jul 9, 2026 under K260539, a traditional 510(k). The device falls under product code FOZ, Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Feb 17, 2026. The decision came 142 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

MedSource Labs, LLC has one other decision in the tracker over the last 12 months: K261041 (ClearSafe Closed System).

Questions & Answers

What did FDA clear under K260539?

K260539 is the FDA 510(k) for MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter, submitted by MedSource Labs, LLC. FDA's decision date was Jul 9, 2026, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter?

MedSource Labs, LLC, based in Chanhassen, MN, is the applicant of record for K260539.

How long did the K260539 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Jul 9, 2026, 142 days later.

← All decisions in July 2026

Sources