Cleared Special

K150491 - ER36 Series OAE Test System (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150491 · Etymotic Research, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
29d
Days
Class 2
Risk

K150491 is an FDA 510(k) clearance for the ER36 Series OAE Test System. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Etymotic Research, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 29 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Etymotic Research, Inc. devices

Submission Details

510(k) Number K150491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2015
Decision Date March 26, 2015
Days to Decision 29 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 89d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 234
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