Cleared Traditional

K012415 - AURIS AEP

K012415 is an FDA 510(k) clearance for AURIS AEP, manufactured by Synapsys, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K012415 · Synapsys, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
141d
Days
Class 2
Risk

K012415 is an FDA 510(k) clearance for the AURIS AEP. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Synapsys, Inc. (Jamaica, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 141 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 - K012415

510(k) Number K012415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date December 18, 2001
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 149d · This submission: 141d
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 75
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K012415.
ECHO-SCREEN T, TA, TD, TDA, TC
K013977 · Fischer-Zoth Audiologic Systems, Inc. · Jun 2002
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp. · May 2002
SABRE COMPAC
K011842 · Sle Limited · Jan 2002
ALGO 3 NEWBORN HEARING SCREENER
K013137 · Natus Medical, Inc. · Oct 2001
MB 11
K011746 · Maico Diagnostic GmbH · Aug 2001
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985 · Ics Medical Corp. · Dec 2000
K012415 · AURIS AEP
Download PDF Synapsys, Inc.