OLWClass II

Index-Generating Electroencephalograph Software

21 CFR 882.1400 / Neurology

OLW is the FDA product code for Index-Generating Electroencephalograph Software, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user". As of 2026-09-10, FDA records hold 40 510(k) clearances under this code, the most recent dated 2026-08-13, and one recall.

Classification record

Product code: OLW
Device name: Index-Generating Electroencephalograph Software
FDA definition: Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Regulation: 21 CFR 882.1400
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 40
Ingested recalls: 1

Clearances, product code OLW

By decision year

40 clearances under product code OLW with a decision year between 1996 and 2026, 2005 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code OLW by decision year
Year	Clearances
1996	1
1998	2
2000	3
2001	4
2002	3
2003	2
2004	4
2005	6
2006	2
2007	3
2008	2
2015	1
2018	1
2021	1
2022	1
2023	1
2024	1
2026	2

Applicants with the most clearances

Product code OLW

Applicants holding the most 510(k) clearances under product code OLW
Applicant	Clearances
Aspect Medical Systems, Inc.	12
GE Healthcare	7
Physiometrix, Inc.	4
Masimo Corporation	3
Medtronic, Inc.	2
Mennen Medical, Inc.	2
Agilent Technologies Deutschland GmbH	1
CareFusion 303, Inc	1
Cortical Dynamics, Ltd.	1
Danmeter A/S	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order