Cleared Traditional

Hypnos (369054-200)

K250851 · Cadwell Industries, Inc. · Neurology
Dec 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K250851 is an FDA 510(k) clearance for the Hypnos (369054-200), a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on December 14, 2025, 268 days after receiving the submission on March 21, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K250851 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2025
Decision Date December 14, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User