Cleared Traditional

K854664 - MEB-5200

K854664 is an FDA 510(k) clearance for MEB-5200, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K854664 · Nihon Kohden America, Inc. · Neurology device
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Aug 1986
Decision
267d
Days
Class 2
Risk

K854664 is an FDA 510(k) clearance for the MEB-5200. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on August 14, 1986 after a review of 267 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 America, Inc. devices

FDA 510(k) Submission Details - K854664

510(k) Number K854664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date August 14, 1986
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 148d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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.