Cleared Traditional

K121847 - TITAN

K121847 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 ETY cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K121847 · Interacoustics A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K121847

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 90d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K121847.
AT235
K151616 · Interacoustics A/S · Jul 2015
GSI TympStar Pro Middle Ear Analyzer
K151509 · Diagnostic Group, Dba Grason-Stadler · Jun 2015
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
K133013 · Inventis S.R.L. · Jan 2014
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
K083861 · Interacoustics AS · Apr 2009
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K081841 · Amplivox, Ltd. · Jul 2008
EARCHECK ACOUSTIC REFLECTOMETER
K070312 · Innovia Medical, LLC · Mar 2007
K121847 · TITAN
Download PDF FDA Summary Interacoustics A/S