Cleared Traditional

K925648 - SMART-SCREENER (AUDITORY)

K925648 is an FDA 510(k) clearance for SMART-SCREENER (AUDITORY), manufactured by Intelligent Hearing Systems. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K925648 · Intelligent Hearing Systems · Neurology device
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May 1993
Decision
183d
Days
Class 2
Risk

K925648 is an FDA 510(k) clearance for the SMART-SCREENER (AUDITORY). Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (North Miami, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 183 days - an extended review 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: 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 - K925648

510(k) Number K925648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date May 11, 1993
Days to Decision 183 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
34d slower than avg
Panel avg: 149d · This submission: 183d
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 66
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K925648.
TECA PREMIERE
K953732 · Medelec , Ltd. · Oct 1995
CLARITY SYSTEM II
K952080 · Sonamed Corp. · Sep 1995
ALGO-2 NEWBORN HEARING SCREENER
K936039 · Natus Medical, Inc. · Jan 1995
MODEL 330 SCREENING AUDIO METER, MODIFIED
K926574 · Virtual Corp. · Mar 1993
DANTEC COUNTERPOINT MK2(TM)
K913957 · Dantec Medical, Inc. · Jan 1992
CORONET 100
K913785 · Micro-Shev , Ltd. · Dec 1991
K925648 · SMART-SCREENER (AUDITORY)
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