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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 / August 2026 / K252571

510(k) cleared

mdprostate

Mediaire GmbH · Aug 7, 2026 · K252571

FDA cleared the mdprostate from Mediaire GmbH on Aug 7, 2026 under K252571, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 14, 2025. The decision came 358 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 Mediaire GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252571?

K252571 is the FDA 510(k) for mdprostate, submitted by Mediaire GmbH. FDA's decision date was Aug 7, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the mdprostate?

Mediaire GmbH, based in Berlin, is the applicant of record for K252571.

How long did the K252571 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Aug 7, 2026, 358 days later.

← All decisions in August 2026