Cleared Traditional

K841568 - IMPEDANCE/PURE TONE AUDIOMETER MA620

K841568 is the FDA 510(k) clearance for IMPEDANCE/PURE TONE AUDIOMETER MA620 by Maico Hearing Instruments, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETY) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K841568 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Jul 1984
Decision
92d
Days
Class 2
Risk

K841568 is an FDA 510(k) clearance for the IMPEDANCE/PURE TONE AUDIOMETER MA620. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 92 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

Submission Details

510(k) Number K841568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date July 18, 1984
Days to Decision 92 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
3d slower than avg
Panel avg: 89d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K841568.
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · Maico Hearing Instruments, Inc. · Apr 1991
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
MA 610-IMPEDANCE AUDIOMETER
K831754 · Maico Hearing Instruments, Inc. · Jul 1983
MA600-IMPEDANCE AUDIOMETER
K831755 · Maico Hearing Instruments, Inc. · Jul 1983
AURAL REFLEX INDICATOR
K822566 · Kelleher Corp. · Sep 1982