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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 / May 2026 / K260560

510(k) cleared

Apollo TMS Therapy System;Apollo light TMS Therapy System

Mag & More GmbH · May 22, 2026 · K260560

FDA cleared the Apollo TMS Therapy System;Apollo light TMS Therapy System from Mag & More GmbH on May 22, 2026 under K260560, a traditional 510(k). The device falls under product code OBP, Transcranial Magnetic Stimulator, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 19, 2026. The decision came 92 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 Mag & More GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260560?

K260560 is the FDA 510(k) for Apollo TMS Therapy System;Apollo light TMS Therapy System, submitted by Mag & More GmbH. FDA's decision date was May 22, 2026, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the Apollo TMS Therapy System;Apollo light TMS Therapy System?

Mag & More GmbH, based in Munich, is the applicant of record for K260560.

How long did the K260560 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on May 22, 2026, 92 days later.

← All decisions in May 2026