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 Masimo Corporation, Neurowave Systems, Inc. and Cortical Dynamics , Ltd..

38
Total
38
Cleared
153d
Avg days
1996
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

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

38 devices
1–24 of 38
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

About Product Code OLW - Regulatory Context

510(k) Submission Activity

38 total 510(k) submissions under product code OLW since 1996, with 38 receiving FDA clearance (average review time: 153 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.