Cleared Traditional

K063452 - MA 55 MAESTRO

K063452 is an FDA 510(k) clearance for MA 55 MAESTRO, manufactured by Maico Diagnostics (Diagnostic Group, LLC). The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K063452 · Maico Diagnostics (Diagnostic Group, LLC) · Ear, Nose, Throat device
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Mar 2007
Decision
134d
Days
Class 2
Risk

K063452 is an FDA 510(k) clearance for the MA 55 MAESTRO. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Diagnostics (Diagnostic Group, LLC) (Eden Prairie, US). The FDA issued a Cleared decision on March 29, 2007 after a review of 134 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 (Diagnostic Group, LLC) devices

FDA 510(k) Submission Details - K063452

510(k) Number K063452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date March 29, 2007
Days to Decision 134 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 90d · This submission: 134d
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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K063452.
GN OTOMETRICS INSERT EARPHONES
K081234 · Gn Otometrics · Jul 2008
OTODYNAMICS OTOPORT
K072033 · Otodynamics, Ltd. · Nov 2007
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K070880 · Etymotic Research, Inc. · Jun 2007
OTOGRAM, CA3350
K070118 · Tympany, Inc. · Mar 2007
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K063338 · Mimosa Acoustics, Inc. · Jan 2007
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · Bio-Logic Systems Corp. · Sep 2006