Cleared Traditional

K841568 - IMPEDANCE/PURE TONE AUDIOMETER MA620

K841568 is an FDA 510(k) clearance for IMPEDANCE/PURE TONE AUDIOMETER MA620, 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 92-day FDA review.

K841568 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K841568

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
2d slower than avg
Panel avg: 90d · This submission: 92d
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 K841568.
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
K874354 · Madsen Electronics (Canada) , Ltd. · Jan 1988
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
Z0174, IMPEDANCE AUDIOMETER
K845049 · Madsen Electronics (Canada) , Ltd. · May 1985
CLINICAL TYMPANOMETER
K833045 · American Electromedics Corp. · Dec 1983
MA 610-IMPEDANCE AUDIOMETER
K831754 · Maico Hearing Instruments, Inc. · Jul 1983
MA600-IMPEDANCE AUDIOMETER
K831755 · Maico Hearing Instruments, Inc. · Jul 1983