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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 / October 2025 / K251366

510(k) cleared

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

Nihon Kohden Corporation · Oct 9, 2025 · K251366

FDA cleared the EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) from Nihon Kohden Corporation on Oct 9, 2025 under K251366, a traditional 510(k). The device falls under product code OLT, Non-Normalizing Quantitative Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 1, 2025. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nihon Kohden Corporation has 2 other decisions in the tracker over the last 12 months: K251641 (GF-310R Multigas Unit (GF-310R)), K260747 (YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff).

Questions & Answers

What did FDA clear under K251366?

K251366 is the FDA 510(k) for EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A), submitted by Nihon Kohden Corporation. FDA's decision date was Oct 9, 2025, under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software).

Who makes the EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)?

Nihon Kohden Corporation, based in Tokyo, is the applicant of record for K251366.

How long did the K251366 review take?

FDA received the submission on May 1, 2025 and issued its decision on Oct 9, 2025, 161 days later.

← All decisions in October 2025

Sources