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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 / October 2025 / K251974

510(k) cleared

Arctic Sun Temperature Management System (Model 5000)

Medivance, Inc. · Oct 24, 2025 · K251974

FDA cleared the Arctic Sun Temperature Management System (Model 5000) from Medivance, Inc. on Oct 24, 2025 under K251974, a traditional 510(k). The device falls under product code DWJ, System, Thermal Regulating, regulated at 21 CFR 870.5900 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 26, 2025. The decision came 120 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 Medivance, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251974?

K251974 is the FDA 510(k) for Arctic Sun Temperature Management System (Model 5000), submitted by Medivance, Inc.. FDA's decision date was Oct 24, 2025, under product code DWJ (System, Thermal Regulating).

Who makes the Arctic Sun Temperature Management System (Model 5000)?

Medivance, Inc., based in Louisville, CO, is the applicant of record for K251974.

How long did the K251974 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Oct 24, 2025, 120 days later.

← All decisions in October 2025