Cleared Traditional

K112992 - EARLOGIC OAE TESTER

K112992 is an FDA 510(k) clearance for EARLOGIC OAE TESTER, manufactured by Earlogic Corporation. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K112992 · Earlogic Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
197d
Days
Class 2
Risk

K112992 is an FDA 510(k) clearance for the EARLOGIC OAE TESTER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Earlogic Corporation (Salt Lake City, US). The FDA issued a Cleared decision on April 20, 2012 after a review of 197 days - an extended review 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: 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 Earlogic Corporation devices

FDA 510(k) Submission Details - K112992

510(k) Number K112992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date April 20, 2012
Days to Decision 197 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 89d · This submission: 197d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K112992.
Sera
K173567 · Interacoustics A/S · Feb 2018
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496 · Bio-Logic Systems Corp. · Nov 2012
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K121512 · Bio-Logic Systems Corp. · Jul 2012
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · Bio-Logic Systems Corp. · Sep 2006
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