Cleared Traditional

K112247 - A BAER WITH ABAER I/O FUNCTION

K112247 is an FDA 510(k) clearance for A BAER WITH ABAER I/O FUNCTION, 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 242-day FDA review.

K112247 · Natus Medical Incorporated · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
242d
Days
Class 2
Risk

K112247 is an FDA 510(k) clearance for the A BAER WITH ABAER 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 April 2, 2012 after a review of 242 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 - K112247

510(k) Number K112247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2011
Decision Date April 02, 2012
Days to Decision 242 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
152d slower than avg
Panel avg: 90d · This submission: 242d
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 K112247.
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K112992 · Earlogic Corporation · Apr 2012
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K111618 · Natus Medical Incorporated · Dec 2011
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K112733 · Etymotic Research, Inc. · Dec 2011
ACAM 5 AUDIOMETER SYSTEM
K103298 · Acousticon GmbH · Apr 2011