Cleared Traditional

K905704 - MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER

K905704 is an FDA 510(k) clearance for MA630 IMPED SCREENER/MA640 IMPED/AUDIOM..., manufactured by Maico Hearing Instruments, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K905704 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
130d
Days
Class 2
Risk

K905704 is an FDA 510(k) clearance for the MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 30, 1991 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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 Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K905704

510(k) Number K905704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date April 30, 1991
Days to Decision 130 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 90d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 45
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K905704.
AE-206 TYMPNOMWRWE(R) AUDIOMETER
K924933 · American Electromedics Corp. · Jan 1993
AUTOMATIC IMPEDANCE METER AE-205
K924934 · American Electromedics Corp. · Jan 1993
ZODIAC 901 MIDDLE-EAR ANALYZER
K910247 · Madsen Electronics (Canada) , Ltd. · Jun 1991
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · American Electromedics Corp. · Feb 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · American Electromedics Corp. · Feb 1991
AE-105D DIAGNOSTIC TYMPANOMETER
K894260 · American Electromedics Corp. · Jan 1990