Cleared Traditional

K060883 - PILOT TEST OR DETECTIVE AUDIOMETERS

K060883 is an FDA 510(k) clearance for PILOT TEST OR DETECTIVE AUDIOMETERS, manufactured by Interacoustics A/S. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K060883 · Interacoustics A/S · Ear, Nose, Throat device
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Jun 2006
Decision
84d
Days
Class 2
Risk

K060883 is an FDA 510(k) clearance for the PILOT TEST OR DETECTIVE AUDIOMETERS. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Interacoustics A/S (Minnesota, US). The FDA issued a Cleared decision on June 23, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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.

FDA 510(k) Submission Details - K060883

510(k) Number K060883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date June 23, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 90d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 - EWO Audiometer

All 203
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K060883.
OTOGRAM, CA3350
K070118 · Tympany, Inc. · Mar 2007
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K063338 · Mimosa Acoustics, Inc. · Jan 2007
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · Bio-Logic Systems Corp. · Sep 2006
MODEL MI 44 TYMPANOMETER
K060885 · Maico-Diagnostics · Jun 2006
DPOAE20 , ECLIPSE
K060539 · Interacoustics A/S, Assens · May 2006
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K053216 · Mimosa Acoustics, Inc. · Feb 2006
K060883 · PILOT TEST OR DETECTIVE AUDIOMETERS
Download PDF Interacoustics A/S