Cleared Traditional

K130795 - TITAN

K130795 is an FDA 510(k) clearance for TITAN, manufactured by Interacoustics A/S. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K130795 · Interacoustics A/S · Ear, Nose, Throat device
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Jun 2013
Decision
90d
Days
Class 2
Risk

K130795 is an FDA 510(k) clearance for the TITAN. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on June 20, 2013 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Interacoustics A/S devices

FDA 510(k) Submission Details - K130795

510(k) Number K130795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2013
Decision Date June 20, 2013
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 90d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 109
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K130795.
Sera
K173567 · Interacoustics A/S · Feb 2018
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K103298 · Acousticon GmbH · Apr 2011