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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 / K253562

510(k) cleared

medilogFD

Schiller AG · Aug 14, 2026 · K253562

FDA cleared the medilogFD from Schiller AG on Aug 14, 2026 under K253562, a traditional 510(k). The device falls under product code MWJ, Electrocardiograph, Ambulatory (Without Analysis), regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 17, 2025. The decision came 270 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 Schiller AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253562?

K253562 is the FDA 510(k) for medilogFD, submitted by Schiller AG. FDA's decision date was Aug 14, 2026, under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)).

Who makes the medilogFD?

Schiller AG, based in Baar, is the applicant of record for K253562.

How long did the K253562 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Aug 14, 2026, 270 days later.

← All decisions in August 2026