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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 / April 2026 / K252464

510(k) cleared

Surgical Microscope (OMS2360, OMS2380)

Zumax Medical Co., Ltd. · Apr 28, 2026 · K252464

FDA cleared the Surgical Microscope (OMS2360, OMS2380) from Zumax Medical Co., Ltd. on Apr 28, 2026 under K252464, a traditional 510(k). The device falls under product code NBL, Light-Induced Fluorescence Caries Detector , regulated at 21 CFR 872.1745 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 6, 2025. The decision came 265 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 Zumax Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252464?

K252464 is the FDA 510(k) for Surgical Microscope (OMS2360, OMS2380), submitted by Zumax Medical Co., Ltd.. FDA's decision date was Apr 28, 2026, under product code NBL (Light-Induced Fluorescence Caries Detector ).

Who makes the Surgical Microscope (OMS2360, OMS2380)?

Zumax Medical Co., Ltd., based in Suzhou, is the applicant of record for K252464.

How long did the K252464 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Apr 28, 2026, 265 days later.

← All decisions in April 2026