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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / February 2026 / K252565

510(k) cleared

PreOp v3

Clouds of Care · Feb 13, 2026 · K252565

FDA cleared the PreOp v3 from Clouds of Care on Feb 13, 2026 under K252565, a special 510(k). The device falls under product code OLX, Source Localization Software For Electroencephalograph Or Magnetoencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 14, 2025. The decision came 183 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 Clouds of Care in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252565?

K252565 is the FDA 510(k) for PreOp v3, submitted by Clouds of Care. FDA's decision date was Feb 13, 2026, under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph).

Who makes the PreOp v3?

Clouds of Care, based in Ghent, is the applicant of record for K252565.

How long did the K252565 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Feb 13, 2026, 183 days later.

← All decisions in February 2026