Cleared Traditional

K863985 - EVOPORT 100

K863985 is an FDA 510(k) clearance for EVOPORT 100, manufactured by Jedmed Instrument Co.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K863985 · Jedmed Instrument Co. · Neurology device
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Jan 1987
Decision
107d
Days
Class 2
Risk

K863985 is an FDA 510(k) clearance for the EVOPORT 100. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on January 29, 1987 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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 Jedmed Instrument Co. devices

FDA 510(k) Submission Details - K863985

510(k) Number K863985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date January 29, 1987
Days to Decision 107 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
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 48
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K863985.
DANTEC COUNTERPOINT MK2(TM)
K913957 · Dantec Medical, Inc. · Jan 1992
TECA/MEDELEC AS-10 SENSOR
K862906 · Teca, Inc. · Feb 1987
TECA/MEDELEC AUDIOSTAR
K863156 · Teca, Inc. · Feb 1987
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361 · Cadwell Laboratories, Inc. · Sep 1986
INSERT EARPHONES
K862363 · Cadwell Laboratories, Inc. · Sep 1986
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K830579 · Nicolet Biomedical Instruments · Mar 1983