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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 / March 2026 / K252037

510(k) cleared

CUVIS-joint (CJ150)

Curexo, Inc. · Mar 25, 2026 · K252037

FDA cleared the CUVIS-joint (CJ150) from Curexo, Inc. on Mar 25, 2026 under K252037, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 30, 2025. The decision came 268 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 Curexo, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252037?

K252037 is the FDA 510(k) for CUVIS-joint (CJ150), submitted by Curexo, Inc.. FDA's decision date was Mar 25, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the CUVIS-joint (CJ150)?

Curexo, Inc., based in Seoul, is the applicant of record for K252037.

How long did the K252037 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Mar 25, 2026, 268 days later.

← All decisions in March 2026