Cleared Traditional

K081841 - AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER

K081841 is an FDA 510(k) clearance for AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE..., manufactured by Amplivox, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K081841 · Amplivox, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
16d
Days
Class 2
Risk

K081841 is an FDA 510(k) clearance for the AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Amplivox, Ltd. (Deer Field, US). The FDA issued a Cleared decision on July 16, 2008 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amplivox, Ltd. devices

FDA 510(k) Submission Details - K081841

510(k) Number K081841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2008
Decision Date July 16, 2008
Days to Decision 16 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 90d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ETY Tester, Auditory Impedance

All 45
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K081841.
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K133013 · Inventis S.R.L. · Jan 2014
TITAN
K121847 · Interacoustics A/S · Nov 2012
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
K083861 · Interacoustics AS · Apr 2009
EARCHECK ACOUSTIC REFLECTOMETER
K070312 · Innovia Medical, LLC · Mar 2007
GSI 2000 MIDDLE EAR ANALYZER
K000097 · Grason-Stadler, Inc. · Apr 2000
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254 · International Distributors of Electronics For Medi · Mar 2000

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.