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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 / December 2025 / K252482

510(k) cleared

CogNet AI-MT+

Medcognetics, Inc. · Dec 11, 2025 · K252482

FDA cleared the CogNet AI-MT+ from Medcognetics, Inc. on Dec 11, 2025 under K252482, a traditional 510(k). The device falls under product code QFM, Radiological Computer-Assisted Prioritization Software For Lesions, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 7, 2025. The decision came 126 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 Medcognetics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252482?

K252482 is the FDA 510(k) for CogNet AI-MT+, submitted by Medcognetics, Inc.. FDA's decision date was Dec 11, 2025, under product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).

Who makes the CogNet AI-MT+?

Medcognetics, Inc., based in Dallas, TX, is the applicant of record for K252482.

How long did the K252482 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Dec 11, 2025, 126 days later.

← All decisions in December 2025