Cleared Traditional

K862361 - 40-HZ AUDITORY EVOKED RESPONSE TEST

K862361 is an FDA 510(k) clearance for 40-HZ AUDITORY EVOKED RESPONSE TEST, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K862361 · Cadwell Laboratories, Inc. · Neurology device
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Sep 1986
Decision
86d
Days
Class 2
Risk

K862361 is an FDA 510(k) clearance for the 40-HZ AUDITORY EVOKED RESPONSE TEST. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on September 17, 1986 after a review of 86 days - a notably fast clearance cycle.

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: 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K862361

510(k) Number K862361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1986
Decision Date September 17, 1986
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 21
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K862361.
TECA/MEDELEC AS-10 SENSOR
K862906 · Teca, Inc. · Feb 1987
TECA/MEDELEC AUDIOSTAR
K863156 · Teca, Inc. · Feb 1987
EVOPORT 100
K863985 · Jedmed Instrument Co. · Jan 1987
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