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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 / K250851

510(k) cleared

Hypnos (369054-200)

Cadwell Industries, Inc. · Dec 14, 2025 · K250851

FDA cleared the Hypnos (369054-200) from Cadwell Industries, Inc. on Dec 14, 2025 under K250851, a traditional 510(k). The device falls under product code OLZ, Automatic Event Detection Software For Polysomnograph With Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 21, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cadwell Industries, Inc. has one other decision in the tracker over the last 12 months: K261442 (Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array).

Questions & Answers

What did FDA clear under K250851?

K250851 is the FDA 510(k) for Hypnos (369054-200), submitted by Cadwell Industries, Inc.. FDA's decision date was Dec 14, 2025, under product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

Who makes the Hypnos (369054-200)?

Cadwell Industries, Inc., based in Kennewick, WA, is the applicant of record for K250851.

How long did the K250851 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Dec 14, 2025, 268 days later.

← All decisions in December 2025

Sources