OLZ · Class II · 21 CFR 882.1400

FDA Product Code OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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

Leading manufacturers include Respironics, Inc., Advanced Brain Monitoring, Inc. and Embla Systems.

Total

Cleared

178d

Avg days

1986

Since

Growing category - 7 submissions in the last 2 years vs 3 in the prior period

Consistent review times: 176d avg (recent)

FDA 510(k) Cleared Automatic Event Detection Software For Polysomnograph With Electroencephalograph Devices (Product Code OLZ)

37 devices

1–24 of 37

Onera SleepMap (SLEEPMAP)

Cadwell Industries, Inc.

Brain Electrophysiology Laboratory Company, LLC

Beacon Biosignals, Inc.

Beacon Biosignals, Inc.

Beacon Biosignals, Inc.

Neumetry Medical, Inc.

Neurozone Msh Incorporated

Natus Neurology Incorporated

Advanced Brain Monitoring, Inc.

Consolidated Research of Richmond, Inc.

Advanced Brain Monitoring, Inc.

Neurology · 105d

About Product Code OLZ - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code OLZ since 1986, with 37 receiving FDA clearance (average review time: 178 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OLZ Product Code

FDA review times for OLZ submissions have been consistent, averaging 176 days recently vs 179 days historically.

OLZ devices are reviewed by the Neurology panel. Browse all Neurology devices →

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Jun 27, 2026

Product Code Info

Code	OLZ
Device class	Class II
CFR	21 CFR 882.1400
Panel	Neurology

Verify on FDA.gov

View OLZ classification on FDA.gov →