Cleared Special

K150491 - ER36 Series OAE Test System

K150491 is an FDA 510(k) clearance for ER36 Series OAE Test System, manufactured by Etymotic Research, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Special 510(k) pathway after a 29-day FDA review.

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

FDA 510(k) Submission Details - K150491

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 90d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Nsf Health Sciences Medical Devices
Meaghan Bailey

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EWO Audiometer

All 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K150491.
GSI Novus
K172403 · Grason-Stadler, Inc. · Oct 2017
Easyscreen
K171506 · Maico Diagnostics GmbH · Aug 2017
iHearTest
K151025 · Ihear Medical, Inc. · Dec 2015
NEURO-AUDIO
K141524 · Teleemg, LLC USA · Mar 2015
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
K143395 · Otodynamics, Ltd. · Feb 2015
SENTIERO
K133012 · Path Medical GmbH · Jun 2014