FDA Product Code OLV: Standard Polysomnograph With Electroencephalograph
Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
Leading manufacturers include Nihon Kohden America, Inc., Neurotronics, Inc. and Grass-Telefactor Product Group.
65
Total
65
Cleared
122d
Avg days
1986
Since
Growing category -
5 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
161d
recently vs 118d historically
FDA 510(k) Cleared Standard Polysomnograph With Electroencephalograph Devices (Product Code OLV)
65 devices
Cleared
Aug 25, 2026
Report Studio
Beacon Biosignals, Inc.
Neurology
90d
Cleared
Mar 20, 2026
Noxturnal Web
Nox Medical Ehf
Neurology
28d
Cleared
Feb 20, 2025
Falcon HST
Compumedics Limited
Neurology
188d
Cleared
Dec 23, 2024
Noxturnal Web
Nox Medical Ehf
Neurology
230d
Cleared
Dec 08, 2024
HomeSleepTest (HST, HST REM+)
Somnomedics GmbH
Neurology
269d
Cleared
Jul 06, 2022
Cerebra Sleep System
Cerebra Medical , Ltd.
Neurology
289d
Cleared
Aug 12, 2020
SOMNOscreen plus
Somnomedics GmbH
Neurology
113d
Cleared
Feb 20, 2020
ApneaTrak
Cadwell Industries, Inc.
Neurology
150d
Cleared
Nov 16, 2018
Serenity Piezo Sensor, Serenity Thermocouple Sensor
Neurotronics, Inc.
Neurology
141d
Cleared
Jul 02, 2018
Serenity Body Position Sensor, Serenity RIP Sensors
Neurotronics, Inc.
Neurology
194d
Cleared
Mar 09, 2018
Grass TWin
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology
98d
Cleared
Dec 19, 2017
Zmachine Synergy
Consolidated Research of Richmond, Inc. Dba General Sleep CO
Neurology
83d
Cleared
Nov 03, 2017
Comet-PLUS
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology
56d
Cleared
Jan 19, 2017
Polysmith Sleep System, Model NTI7593
Neurotronics, Inc.
Neurology
218d
Cleared
Feb 18, 2015
Polysmith Sleep System
Neurotronics, Inc.
Neurology
145d
Cleared
Aug 09, 2013
LIVE VIEW PANEL (LVP)
Neurotronics, Inc.
Neurology
85d
Cleared
Dec 21, 2011
GALAXY SYSTEM
Personal Health Institute International
Neurology
250d
Cleared
Jan 11, 2008
EEG-1100A SWITCH BOX
Nihon Kohden America, Inc.
Neurology
30d
Cleared
Jan 10, 2008
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
Micromed S.P.A.
Neurology
192d
Cleared
Oct 20, 2005
AURA-PSG
Astro-Med, Inc.
Neurology
244d
Cleared
Aug 26, 2005
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
Bio-Logic Systems Corp.
Neurology
25d
Cleared
Apr 29, 2005
ELECTRODE JUNCTION BOX, MODEL JE-921A
Nihon Kohden America, Inc.
Neurology
28d
Cleared
Feb 01, 2005
OMNIPRO SYSTEM
Mays and Associates, Inc.
Neurology
11d
Cleared
Nov 17, 2004
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
Cleveland Medical Devices, Inc.
Neurology
111d
About Product Code OLV - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code OLV since 1986, with 65 receiving FDA clearance (average review time: 122 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OLV Product Code
Recent submissions under OLV have taken an average of 161 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.
OLV devices are reviewed by the Neurology panel. Browse all Neurology devices →