Cleared Traditional

K052562 - ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.

K052562 is an FDA 510(k) clearance for ECLIPSE (CABINET NAME), manufactured by Interacoustics AS. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K052562 · Interacoustics AS · Ear, Nose, Throat device
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Dec 2005
Decision
95d
Days
Class 2
Risk

K052562 is an FDA 510(k) clearance for the ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Interacoustics AS (Minnesota, US). The FDA issued a Cleared decision on December 23, 2005 after a review of 95 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 AS devices

FDA 510(k) Submission Details - K052562

510(k) Number K052562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2005
Decision Date December 23, 2005
Days to Decision 95 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
5d slower than avg
Panel avg: 90d · This submission: 95d
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 K052562.
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
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · Interacoustics AS · Feb 2005
BIO-LOGIC INSERT EARPHONES
K031352 · Bio-Logic Systems Corp. · Jul 2003
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · Bio-Logic Systems Corp. · Jun 2002