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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 / December 2025 / K252951

510(k) cleared

Genesis Sleep

Neurofield, Inc. · Dec 31, 2025 · K252951

FDA cleared the Genesis Sleep from Neurofield, Inc. on Dec 31, 2025 under K252951, a traditional 510(k). The device falls under product code QJQ, Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety, regulated at 21 CFR 882.5800 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 16, 2025. The decision came 106 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 Neurofield, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252951?

K252951 is the FDA 510(k) for Genesis Sleep, submitted by Neurofield, Inc.. FDA's decision date was Dec 31, 2025, under product code QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety).

Who makes the Genesis Sleep?

Neurofield, Inc., based in Santa Barbara, CA, is the applicant of record for K252951.

How long did the K252951 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Dec 31, 2025, 106 days later.

← All decisions in December 2025