Cleared Traditional

K913785 - CORONET 100

K913785 is an FDA 510(k) clearance for CORONET 100, manufactured by Micro-Shev , Ltd.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K913785 · Micro-Shev , Ltd. · Neurology device
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Dec 1991
Decision
130d
Days
Class 2
Risk

K913785 is an FDA 510(k) clearance for the CORONET 100. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Micro-Shev , Ltd. (Efrat, IL). The FDA issued a Cleared decision on December 31, 1991 after a review of 130 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.

FDA 510(k) Submission Details - K913785

510(k) Number K913785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date December 31, 1991
Days to Decision 130 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 149d · This submission: 130d
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 60
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K913785.
SMART-SCREENER (AUDITORY)
K925648 · Intelligent Hearing Systems · May 1993
MODEL 330 SCREENING AUDIO METER, MODIFIED
K926574 · Virtual Corp. · Mar 1993
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
EVOPORT 100
K863985 · Jedmed Instrument Co. · Jan 1987