OLW · Class II · 21 CFR 882.1400

FDA Product Code OLW: Index-generating Electroencephalograph Software

Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.

Leading manufacturers include Aspect Medical Systems, Inc., Physiometrix, Inc. and Masimo Corporation.

40
Total
40
Cleared
152d
Avg days
1996
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times: 131d avg (recent)

FDA 510(k) Cleared Index-generating Electroencephalograph Software Devices (Product Code OLW)

40 devices
1–24 of 40
Cleared Aug 13, 2026
BIS™ Advance pEEG Module
K260907
Covidien LP
Anesthesiology · 147d
Cleared Jul 10, 2026
SedLine Sedation Monitor
K260880
Masimo Corporation
Anesthesiology · 115d
Cleared Feb 26, 2024
BIS™ Advance Monitoring System
K230693
Covidien, LLC
Anesthesiology · 350d
Cleared Sep 01, 2023
Brain Anesthesia Response Monitor (Bar Monitor)
K213273
Cortical Dynamics , Ltd.
Anesthesiology · 701d
Cleared Feb 25, 2022
Masimo SedLine Sedation Monitor and Accessories
K203113
Masimo Corporation
Anesthesiology · 498d
Cleared Aug 05, 2021
NeuroSENSE Monitoring System, Model NS-901
K202621
Neurowave Systems, Inc.
Anesthesiology · 329d
Cleared Jan 26, 2018
SedLine Sedation Monitor
K172890
Masimo Corporation
Neurology · 126d
Cleared Nov 12, 2015
Entropy Module, E-ENTROPY-01
K150298
Ge Healthcare Filand OY
Neurology · 279d
Cleared Dec 16, 2008
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
K083063
Mennen Medical , Ltd.
Neurology · 63d
Cleared Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907
Ge Healthcare
Neurology · 631d
Cleared Nov 20, 2007
BIS EEG VISTA MONITOR SYSTEM AND BISX
K072286
Aspect Medical Systems, Inc.
Neurology · 96d
Cleared Oct 22, 2007
BIS MODULE FOR ENVOY PATIENT MONITOR
K071899
Mennen Medical , Ltd.
Neurology · 105d
Cleared Jun 18, 2007
BIS EEG MONITOR VIEW
K062613
Aspect Medical Systems, Inc.
Neurology · 286d
Cleared Jun 23, 2006
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K060900
Spacelabs Medical, Inc.
Neurology · 81d
Cleared Nov 01, 2005
BIS EEG MONITOR, MODEL BISX4
K052981
Aspect Medical Systems, Inc.
Neurology · 8d
Cleared Sep 09, 2005
BIS EEG MONITOR, MODEL A-3000
K052362
Aspect Medical Systems, Inc.
Neurology · 11d
Cleared Sep 02, 2005
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
K051874
Physiometrix, Inc.
Neurology · 53d
Cleared Aug 23, 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145
Ge Healthcare
Neurology · 15d
Cleared May 06, 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835
Ge Healthcare
Neurology · 35d
Cleared Jan 21, 2005
CEREBRAL STATE MONITOR - CSM
K042315
Danmeter A/S
Neurology · 148d
Cleared Feb 25, 2004
BISX
K040183
Aspect Medical Systems, Inc.
Neurology · 29d
Cleared Feb 06, 2004
SEDLINE WITH FRONTAL PSI
K033999
Physiometrix, Inc.
Neurology · 44d
Cleared Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267
Aspect Medical Systems, Inc.
Neurology · 353d
Cleared Aug 29, 2003
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
K031694
Aspect Medical Systems, Inc.
Neurology · 88d

About Product Code OLW - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code OLW since 1996, with 40 receiving FDA clearance (average review time: 152 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - OLW Product Code

FDA review times for OLW submissions have been consistent, averaging 131 days recently vs 153 days historically.

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