Cleared Traditional

K121847 - TITAN

K121847 is the FDA 510(k) clearance for TITAN by Interacoustics A/S. It is a Class 2 Ear, Nose, Throat device (product code ETY) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K121847 · Interacoustics A/S · Ear, Nose, Throat device
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Nov 2012
Decision
157d
Days
Class 2
Risk

K121847 is an FDA 510(k) clearance for the TITAN. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on November 29, 2012 after a review of 157 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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

Submission Details

510(k) Number K121847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2012
Decision Date November 29, 2012
Days to Decision 157 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 89d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 11
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K905704 · Maico Hearing Instruments, Inc. · Apr 1991
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K883293 · Storz Instrument Co. · Jun 1989