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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 / September 2025 / K252524

510(k) cleared

Quadsense (Quadsense and Quadsense Pro)

Eventum Orthopaedics, Ltd. · Sep 9, 2025 · K252524

FDA cleared the Quadsense (Quadsense and Quadsense Pro) from Eventum Orthopaedics, Ltd. on Sep 9, 2025 under K252524, a special 510(k). The device falls under product code ONN, Intraoperative Orthopedic Joint Assessment Aid, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 11, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Eventum Orthopaedics, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252524?

K252524 is the FDA 510(k) for Quadsense (Quadsense and Quadsense Pro), submitted by Eventum Orthopaedics, Ltd.. FDA's decision date was Sep 9, 2025, under product code ONN (Intraoperative Orthopedic Joint Assessment Aid).

Who makes the Quadsense (Quadsense and Quadsense Pro)?

Eventum Orthopaedics, Ltd., based in Leeds, is the applicant of record for K252524.

How long did the K252524 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Sep 9, 2025, 29 days later.

← All decisions in September 2025