Cleared Traditional

K083861 - TITAN

K083861 is an FDA 510(k) clearance for TITAN, manufactured by Interacoustics AS. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K083861 · Interacoustics AS · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
106d
Days
Class 2
Risk

K083861 is an FDA 510(k) clearance for the TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 .... Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Interacoustics AS (Assens, DK). The FDA issued a Cleared decision on April 9, 2009 after a review of 106 days - within the typical 510(k) review window.

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 AS devices

FDA 510(k) Submission Details - K083861

510(k) Number K083861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date April 09, 2009
Days to Decision 106 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
17d slower than avg
Panel avg: 89d · This submission: 106d
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 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K083861.
Hearing Healthcare Pro
K183201 · Db Diagnostic Systems, Inc. · Mar 2019
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
K953161 · Maico Hearing Instruments, Inc. · Jul 1995
HANDTYMP
K923072 · Life-Tech Intl., Inc. · Mar 1993
AUTOMATIC TYMPANOMETER
K923073 · Life-Tech Intl., Inc. · Feb 1993
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · Maico Hearing Instruments, Inc. · Apr 1991
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989