Cleared Special

K031009 - MODIFICATION TO BIO-LOGIC EVOKED POTENT...

K031009 is an FDA 510(k) clearance for MODIFICATION TO BIO-LOGIC EVOKED POTENT..., manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code GWJ cleared through the Special 510(k) pathway after a 28-day FDA review.

K031009 · Bio-Logic Systems Corp. · Neurology device
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Apr 2003
Decision
28d
Days
Class 2
Risk

K031009 is an FDA 510(k) clearance for the MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on April 28, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K031009

510(k) Number K031009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date April 28, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 21
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K031009.
GSI Audera Pro
K193033 · Grason Stadler · Apr 2020
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp. · May 2003
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp. · Jul 2002
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp. · May 2002
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999