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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 / September 2025 / K251449

510(k) cleared

BrainsWay Deep TMS System

Brainsway , Ltd. · Sep 13, 2025 · K251449

FDA cleared the BrainsWay Deep TMS System from Brainsway , Ltd. on Sep 13, 2025 under K251449, 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 May 9, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Brainsway , Ltd. has one other decision in the tracker over the last 12 months: K251391 (BrainsWay Deep TMS System).

Questions & Answers

What did FDA clear under K251449?

K251449 is the FDA 510(k) for BrainsWay Deep TMS System, submitted by Brainsway , Ltd.. FDA's decision date was Sep 13, 2025, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the BrainsWay Deep TMS System?

Brainsway , Ltd., based in Jerusalem, is the applicant of record for K251449.

How long did the K251449 review take?

FDA received the submission on May 9, 2025 and issued its decision on Sep 13, 2025, 127 days later.

← All decisions in September 2025

Sources