OLV · Class II · 21 CFR 882.1400

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 Somnomedics GmbH.

Total

Cleared

122d

Avg days

1986

Since

Growing category - 4 submissions in the last 2 years vs 1 in the prior period

Review times increasing: avg 179d recently vs 118d historically

FDA 510(k) Cleared Standard Polysomnograph With Electroencephalograph Devices (Product Code OLV)

64 devices

1–24 of 64

HomeSleepTest (HST, HST REM+)

Cerebra Medical , Ltd.

Cadwell Industries, Inc.

Neurology · 150d

Cleared Nov 16, 2018

Serenity Piezo Sensor, Serenity Thermocouple Sensor

Serenity Body Position Sensor, Serenity RIP Sensors

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

Nihon Kohden America, Inc.

Neurology · 30d

Cleared Apr 29, 2005

ELECTRODE JUNCTION BOX, MODEL JE-921A

K050833

Nihon Kohden America, Inc.

Neurology · 28d

Cleared Jan 07, 2004

WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES

K033475

Nihon Kohden America, Inc.

Neurology · 65d

Cleared Jul 29, 2002

PSG INPUT BOX, MODEL JE-912AK

K022121

Nihon Kohden America, Inc.

Neurology · 28d

Cleared May 08, 2001

NEUROFAX, MODELS EEG-1100A, EEG-9100A

K011204

Nihon Kohden America, Inc.

Nihon Kohden America, Inc.

Neurology · 83d

Cleared Oct 14, 1999

NEUROFAX, MODEL EEG-1100A

K992742

Nihon Kohden America, Inc.

Neurology · 59d

Cleared Dec 01, 1998

AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201

K983072

Nihon Kohden America, Inc.

Neurology · 90d

Cleared Jun 05, 1986

4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH

K854665

Nihon Kohden America, Inc.

Neurology · 197d

About Product Code OLV - Regulatory Context

510(k) Submission Activity

64 total 510(k) submissions under product code OLV since 1986, with 64 receiving FDA clearance (average review time: 122 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 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 179 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 →

FDA Product Code OLV: Standard Polysomnograph With Electroencephalograph

FDA 510(k) Cleared Standard Polysomnograph With Electroencephalograph Devices (Product Code OLV)

About Product Code OLV - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - OLV Product Code

Related FDA 510(k) Regulatory Insights