Cleared Traditional

K111618 - AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

K111618 is an FDA 510(k) clearance for AUDX OTOACOUSTIC EMISSIONS MEASUREMENT ..., manufactured by Natus Medical Incorporated. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K111618 · Natus Medical Incorporated · Ear, Nose, Throat device
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Dec 2011
Decision
201d
Days
Class 2
Risk

K111618 is an FDA 510(k) clearance for the AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Natus Medical Incorporated (San Francisco, US). The FDA issued a Cleared decision on December 28, 2011 after a review of 201 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 Natus Medical Incorporated devices

FDA 510(k) Submission Details - K111618

510(k) Number K111618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2011
Decision Date December 28, 2011
Days to Decision 201 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 90d · This submission: 201d
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 114
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K111618.
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K121512 · Bio-Logic Systems Corp. · Jul 2012
EARLOGIC OAE TESTER
K112992 · Earlogic Corporation · Apr 2012
A BAER WITH ABAER I/O FUNCTION
K112247 · Natus Medical Incorporated · Apr 2012
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K112733 · Etymotic Research, Inc. · Dec 2011
ACAM 5 AUDIOMETER SYSTEM
K103298 · Acousticon GmbH · Apr 2011
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · Bio-Logic Systems Corp. · Sep 2006