Cleared Traditional

K904165 - SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT

K904165 is an FDA 510(k) clearance for SENSORY NERVE CONDUCTION VELOCITY TESTI..., manufactured by Occupational Preventive Diagnostics, Inc.. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K904165 · Occupational Preventive Diagnostics, Inc. · Neurology device
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May 1991
Decision
259d
Days
Class 2
Risk

K904165 is an FDA 510(k) clearance for the SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Occupational Preventive Diagnostics, Inc. (Lester, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 259 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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 Occupational Preventive Diagnostics, Inc. devices

FDA 510(k) Submission Details - K904165

510(k) Number K904165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date May 28, 1991
Days to Decision 259 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 148d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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 - JXE Device, Nerve Conduction Velocity Measurement

All 15
Devices cleared under the same product code (JXE) and FDA review panel - the closest regulatory comparables to K904165.
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
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REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
K921504 · Chalgren Enterprises, Inc. · Sep 1992
CADWELL 5200
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