Cleared Traditional

K904926 - SMART-EP

K904926 is the FDA 510(k) clearance for SMART-EP by Intelligent Hearing Systems. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K904926 · Intelligent Hearing Systems · Neurology device
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Aug 1991
Decision
275d
Days
Class 2
Risk

K904926 is an FDA 510(k) clearance for the SMART-EP. 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 August 2, 1991 after a review of 275 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.

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Submission Details

510(k) Number K904926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date August 02, 1991
Days to Decision 275 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 148d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.