Cleared Traditional

K060539 - DPOAE20 , ECLIPSE

K060539 is an FDA 510(k) clearance for DPOAE20, manufactured by Interacoustics A/S, Assens. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060539 · Interacoustics A/S, Assens · Ear, Nose, Throat device
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May 2006
Decision
90d
Days
Class 2
Risk

K060539 is an FDA 510(k) clearance for the DPOAE20 , ECLIPSE. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Interacoustics A/S, Assens (Minnesota, US). The FDA issued a Cleared decision on May 30, 2006 after a review of 90 days - within the typical 510(k) review window.

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: 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 A/S, Assens devices

FDA 510(k) Submission Details - K060539

510(k) Number K060539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2006
Decision Date May 30, 2006
Days to Decision 90 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
At panel average
Panel avg: 90d · This submission: 90d
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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K060539.
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · Bio-Logic Systems Corp. · Sep 2006
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883 · Interacoustics A/S · Jun 2006
MODEL MI 44 TYMPANOMETER
K060885 · Maico-Diagnostics · Jun 2006
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K053216 · Mimosa Acoustics, Inc. · Feb 2006
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K052562 · Interacoustics AS · Dec 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · Interacoustics AS · Feb 2005