Cleared Traditional

K031051 - SMARTEP-ASSR, MODEL M811007

K031051 is an FDA 510(k) clearance for SMARTEP-ASSR, 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 324-day FDA review.

K031051 · Intelligent Hearing Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
324d
Days
Class 2
Risk

K031051 is an FDA 510(k) clearance for the SMARTEP-ASSR, MODEL M811007. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Intelligent Hearing Systems devices

FDA 510(k) Submission Details - K031051

510(k) Number K031051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2003
Decision Date February 20, 2004
Days to Decision 324 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 148d · This submission: 324d
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 27
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K031051.
TITAN
K103760 · Interacoustics A/S · May 2011
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K070696 · Interacoustics A/S · Jun 2007
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp. · May 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · Bio-Logic Systems Corp. · Apr 2003
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp. · Jul 2002