Cleared Traditional

K870567 - EVOPORT 300

K870567 is the FDA 510(k) clearance for EVOPORT 300 by Dantec Electronics, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K870567 · Dantec Electronics, Inc. · Neurology device
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Oct 1987
Decision
238d
Days
Class 2
Risk

K870567 is an FDA 510(k) clearance for the EVOPORT 300. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on October 6, 1987 after a review of 238 days - an extended review 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: 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 Dantec Electronics, Inc. devices

Submission Details

510(k) Number K870567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date October 06, 1987
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 148d · This submission: 238d
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 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K870567.
HIGH SPEED MAGNETIC STIMULATOR
K905059 · Cadwell Laboratories, Inc. · Sep 1991
MEM-7102
K890274 · Nihon Kohden America, Inc. · May 1989
CADWELL EXCEL
K880088 · Cadwell Laboratories, Inc. · May 1988
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · Novametrix Medical Systems, Inc. · Aug 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · Cadwell Laboratories, Inc. · Jan 1987
TRAVELER LT
K862690 · Bio-Logic Systems Corp. · Nov 1986