Cleared Traditional

K850108 - EMG SURFACE

K850108 is the FDA 510(k) clearance for EMG SURFACE by Nicolet Biomedical Instruments. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K850108 · Nicolet Biomedical Instruments · Neurology device
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Apr 1985
Decision
91d
Days
Class 2
Risk

K850108 is an FDA 510(k) clearance for the EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K850108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1985
Decision Date April 11, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 147
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K850108.
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · Empi · Dec 1985
TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851175 · Medical Devices, Inc. · Jun 1985
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984
TENZCARE MUSCLE STIMULATION ELECTRODES
K831104 · 3M Company · May 1983