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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 / K261041

510(k) cleared

ClearSafe Closed System

MedSource Labs, LLC · Jul 10, 2026 · K261041

FDA cleared the ClearSafe Closed System from MedSource Labs, LLC on Jul 10, 2026 under K261041, 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 Mar 31, 2026. The decision came 101 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: K260539 (MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter).

Questions & Answers

What did FDA clear under K261041?

K261041 is the FDA 510(k) for ClearSafe Closed System, submitted by MedSource Labs, LLC. FDA's decision date was Jul 10, 2026, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the ClearSafe Closed System?

MedSource Labs, LLC, based in Chanhassen, MN, is the applicant of record for K261041.

How long did the K261041 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Jul 10, 2026, 101 days later.

← All decisions in July 2026

Sources