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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 / August 2026 / K261437

510(k) cleared

Mistral-Air® Warming System

The Surgical Company International B.V., doing business as TSC Life · Aug 7, 2026 · K261437

FDA cleared the Mistral-Air® Warming System from The Surgical Company International B.V., doing business as TSC Life on Aug 7, 2026 under K261437, a special 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 Apr 30, 2026. The decision came 99 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

The Surgical Company International B.V., doing business as TSC Life has one other decision in the tracker over the last 12 months: K252636 (Fluido Compact System).

Questions & Answers

What did FDA clear under K261437?

K261437 is the FDA 510(k) for Mistral-Air® Warming System, submitted by The Surgical Company International B.V., doing business as TSC Life. FDA's decision date was Aug 7, 2026, under product code DWJ (System, Thermal Regulating).

Who makes the Mistral-Air® Warming System?

The Surgical Company International B.V., doing business as TSC Life, based in Amsterdam, is the applicant of record for K261437.

How long did the K261437 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Aug 7, 2026, 99 days later.

← All decisions in August 2026

Sources