Cleared Traditional

K073384 - SMART COUPLER, MODEL M015401

K073384 is an FDA 510(k) clearance for SMART COUPLER, 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 87-day FDA review.

K073384 · Intelligent Hearing Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
87d
Days
Class 2
Risk

K073384 is an FDA 510(k) clearance for the SMART COUPLER, MODEL M015401. 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 28, 2008 after a review of 87 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.

FDA 510(k) Submission Details - K073384

510(k) Number K073384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date February 28, 2008
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
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: 149d · This submission: 87d
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 K073384.
ICS CHARTR EP 200
K083399 · Gn Otometrics A/S · Feb 2009
MAICO MB 11 WITH BERAPHONE PROBE
K082035 · Maico-Diagnostics · Jan 2009
VIVOSONIC NEUROSCREEN
K080060 · Vivosonic, Inc. · Apr 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008
ALGO 5 NEWBORN HEARING SCREENER
K073665 · Natus Medical, Inc. · Jan 2008
SMARTEP, MODEL M010000
K070608 · Intelligent Hearing Systems · Jul 2007
K073384 · SMART COUPLER, MODEL M015401
Download PDF FDA Summary Intelligent Hearing S…