Cleared Traditional

K851300 - NEUROPACK 8, MEE-4108 (FDA 510(k) Clearance)

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

K851300 · Nihon Kohden America, Inc. · Neurology device
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Jun 1985
Decision
73d
Days
Class 2
Risk

K851300 is an FDA 510(k) clearance for the NEUROPACK 8, MEE-4108. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K851300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date June 13, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
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 138
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