Cleared Traditional

K081841 - AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081841 · Amplivox, Ltd. · Ear, Nose, Throat device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 89d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.