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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 / November 2025 / K243981

510(k) cleared

Hexoskin Medical System (7100-00016)

Carre Technologies, Inc. · Nov 18, 2025 · K243981

FDA cleared the Hexoskin Medical System (7100-00016) from Carre Technologies, Inc. on Nov 18, 2025 under K243981, a traditional 510(k). The device falls under product code DXH, Transmitters And Receivers, Electrocardiograph, Telephone, regulated at 21 CFR 870.2920 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 23, 2024. The decision came 330 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 Carre Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243981?

K243981 is the FDA 510(k) for Hexoskin Medical System (7100-00016), submitted by Carre Technologies, Inc.. FDA's decision date was Nov 18, 2025, under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

Who makes the Hexoskin Medical System (7100-00016)?

Carre Technologies, Inc., based in Montreal, is the applicant of record for K243981.

How long did the K243981 review take?

FDA received the submission on Dec 23, 2024 and issued its decision on Nov 18, 2025, 330 days later.

← All decisions in November 2025