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 Ge Healthcare, Masimo Corporation and Datex-Ohmeda.

39
Total
39
Cleared
152d
Avg days
1996
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 115d recently vs 153d historically

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

39 devices
1–24 of 39
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 Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907
Ge Healthcare
Neurology · 631d
Cleared Jun 23, 2006
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K060900
Spacelabs Medical, Inc.
Neurology · 81d
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 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459
Datex-Ohmeda
Neurology · 90d
Cleared Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389
Datex-Ohmeda
Neurology · 90d
Cleared Feb 03, 1998
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
K973596
Spacelabs Medical, Inc.
Neurology · 134d

About Product Code OLW - Regulatory Context

510(k) Submission Activity

39 total 510(k) submissions under product code OLW since 1996, with 39 receiving FDA clearance (average review time: 152 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - OLW Product Code

Recent submissions under OLW have taken an average of 115 days to reach a decision - down from 153 days historically, suggesting improved FDA processing for this classification.

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