Cleared Traditional

MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM (K120397) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120397 · Nihon Kohden Corp. · Neurology device
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Sep 2012
Decision
224d
Days
Class 2
Risk

K120397 is an FDA 510(k) clearance for the MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on September 19, 2012 after a review of 224 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nihon Kohden Corp. devices

Submission Details

510(k) Number K120397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2012
Decision Date September 19, 2012
Days to Decision 224 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 148d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 26
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K120397.
Neuro-IOM system with Neuro-IOM.NET software
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NIM Vital, Nerve Integrity Monitor
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The EPAD 2 System
K182542 · Safeop Surgical, Inc. · Feb 2019
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
K094054 · Nuvasive, Inc. · May 2010
NUVASIVE NEURO VISION SYSTEM
K090298 · Nuvasive, Inc. · Jun 2009
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008