Cleared Traditional

K171506 - Easyscreen

K171506 is an FDA 510(k) clearance for Easyscreen, manufactured by Maico Diagnostics GmbH. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K171506 · Maico Diagnostics GmbH · Ear, Nose, Throat device
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Aug 2017
Decision
98d
Days
Class 2
Risk

K171506 is an FDA 510(k) clearance for the Easyscreen. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Diagnostics GmbH (Berlin, DE). The FDA issued a Cleared decision on August 29, 2017 after a review of 98 days - within the typical 510(k) review window.

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 Maico Diagnostics GmbH devices

FDA 510(k) Submission Details - K171506

510(k) Number K171506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2017
Decision Date August 29, 2017
Days to Decision 98 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
9d slower than avg
Panel avg: 89d · This submission: 98d
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 K171506.
Lyra
K191372 · Interacoustics A/S · Jul 2019
GSI Corti
K180287 · Grason-Stadler, Inc. · May 2018
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