Cleared Traditional

TITAN (K103760) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103760 · Interacoustics A/S · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
133d
Days
Class 2
Risk

K103760 is an FDA 510(k) clearance for the TITAN. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on May 5, 2011 after a review of 133 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.

View all Interacoustics A/S devices

Submission Details

510(k) Number K103760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date May 05, 2011
Days to Decision 133 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
15d faster than avg
Panel avg: 148d · This submission: 133d
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.

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 K103760.
Integrity V500 (Integrity, Integrity with VEMP)
K242954 · Vivosonic, Inc. · Dec 2024
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K233649 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Mar 2024
QScreen
K220139 · Path Medical GmbH · Aug 2022
ALGO 7i
K211147 · Path Medical GmbH · Oct 2021
GSI Audera Pro
K193033 · Grason Stadler · Apr 2020