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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 / K261367

510(k) cleared

Corsano CardioWatch 287-2 System

Corsano Health B.V. · Jul 26, 2026 · K261367

FDA cleared the Corsano CardioWatch 287-2 System from Corsano Health B.V. on Jul 26, 2026 under K261367, a traditional 510(k). The device falls under product code MSX, System, Network And Communication, Physiological Monitors, regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 27, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Corsano Health B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261367?

K261367 is the FDA 510(k) for Corsano CardioWatch 287-2 System, submitted by Corsano Health B.V.. FDA's decision date was Jul 26, 2026, under product code MSX (System, Network And Communication, Physiological Monitors).

Who makes the Corsano CardioWatch 287-2 System?

Corsano Health B.V., based in The Hague, is the applicant of record for K261367.

How long did the K261367 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Jul 26, 2026, 90 days later.

← All decisions in July 2026