Cleared Traditional

K832510 - EVOKED POTENTIALS SYSTEM MK10

K832510 is an FDA 510(k) clearance for EVOKED POTENTIALS SYSTEM MK10, manufactured by Amplaid USA, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K832510 · Amplaid USA, Inc. · Neurology device
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Nov 1983
Decision
121d
Days
Class 2
Risk

K832510 is an FDA 510(k) clearance for the EVOKED POTENTIALS SYSTEM MK10. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Amplaid USA, Inc. (Walker, US). The FDA issued a Cleared decision on November 25, 1983 after a review of 121 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 Amplaid USA, Inc. devices

FDA 510(k) Submission Details - K832510

510(k) Number K832510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date November 25, 1983
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
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 K832510.
EVOPORT 100
K863985 · Jedmed Instrument Co. · Jan 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
AUDIOMETERS (VARIOUS MODELS)
K822177 · Kelleher Corp. · Aug 1982
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K813009 · Teca, Inc. · Dec 1981