Cleared Traditional

K854513 - EMPI

K854513 is the FDA 510(k) clearance for EMPI by Empi. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K854513 · Empi · Neurology device
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Dec 1985
Decision
24d
Days
Class 2
Risk

K854513 is an FDA 510(k) clearance for the EMPI, NMS/SUE CUTANEOUS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Empi (Minneapolis, US). The FDA issued a Cleared decision on December 6, 1985 after a review of 24 days - a notably fast clearance cycle.

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: 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 Empi devices

Submission Details

510(k) Number K854513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 06, 1985
Days to Decision 24 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
124d faster than avg
Panel avg: 148d · This submission: 24d
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 139
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K854513.
EMPI, MODEL 1000 HAND HELD ELECTRODE
K862231 · Empi · Aug 1986
ULTRAHESIVE II POSTOP ELECTRODE
K862028 · Medical Devices, Inc. · Aug 1986
JELTRODE
K861956 · Henley Intl. · Jun 1986
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