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., Beacon Biosignals, Inc. and Nox Medical Ehf.

37
Total
37
Cleared
178d
Avg days
1986
Since
Growing category - 7 submissions in the last 2 years vs 4 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
Cleared Mar 08, 2026
Onera SleepMap (SLEEPMAP)
K253668
Onera B.V.
Neurology · 107d
Cleared Dec 14, 2025
Hypnos (369054-200)
K250851
Cadwell Industries, Inc.
Neurology · 268d
Cleared Nov 17, 2025
DeepRESP
K252330
Nox Medical Ehf
Neurology · 115d
Cleared Apr 10, 2025
NEAT 001
K250058
Brain Electrophysiology Laboratory Company, LLC
Neurology · 90d
Cleared Mar 14, 2025
DeepRESP
K241960
Nox Medical Ehf
Neurology · 254d
Cleared Nov 22, 2024
Dreem 3S
K242094
Beacon Biosignals, Inc.
Neurology · 128d
Cleared Mar 08, 2024
SleepStageML
K233438
Beacon Biosignals, Inc.
Neurology · 147d
Cleared Aug 18, 2023
Dreem 3S
K223539
Beacon Biosignals, Inc.
Neurology · 268d
Cleared Aug 16, 2023
SOMNUM (V.1.1.2.)
K223922
Honeynaps Co., Ltd.
Neurology · 229d
Cleared Sep 21, 2022
SomnoMetry
K221179
Neumetry Medical, Inc.
Neurology · 149d
Cleared Jun 16, 2021
EnsoSleep
K210034
Ensodata, Inc.
Neurology · 161d
Cleared Oct 29, 2020
Sleepware G3
K202142
Respironics, Inc.
Neurology · 90d
Cleared Nov 13, 2019
Nox Sleep System
K192469
Nox Medical
Neurology · 65d
Cleared Jan 17, 2019
Esprit Nova
K182227
Neurozone Msh Incorporated
Neurology · 154d
Cleared Jul 20, 2018
NicoletOne
K173366
Natus Neurology Incorporated
Neurology · 267d
Cleared Mar 16, 2015
Sleepware G3
K142988
Respironics, Inc.
Neurology · 151d
Cleared Mar 18, 2004
ALICE 5
K040595
Respironics, Inc.
Neurology · 10d
Cleared Jun 01, 1989
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K891383
Oxford Medilog, Inc.
Neurology · 84d
Cleared Oct 07, 1987
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
K871990
Oxford Medilog, Inc.
Neurology · 134d

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 4 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 →