510(k) · Neurology

SleepStageML

by Beacon Biosignals, Inc.

SleepStageML is an AI-enabled medical device from Beacon Biosignals, Inc. that the U.S. FDA cleared through 510(k) K233438 on March 8, 2024. Its lead review panel is Neurology and its primary product code is OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

See also FDA-cleared AI neurology devices in 2024, all FDA AI clearances in 2024, top neurology AI devices.

Key facts

Submission numberK233438
Pathway510(k)
Date of final decision
Company (FDA list)Beacon Biosignals, Inc.
Lead review panelNeurology
Primary product codeOLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant (openFDA)Beacon Biosignals, Inc.
Applicant locationBoston, MA, US
Device classClass 2
Regulation number21 CFR 882.1400
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. SleepStageML went through this pathway (K233438).

openFDA lists it as a Class 2 device under 21 CFR 882.1400. Class II devices are moderate risk and are subject to general and special controls.

Product code OLZ covers 9 devices on the FDA AI list. By decision date, this device is #4 of 9 under that code. Beacon Biosignals, Inc. has 3 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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