Cleared Traditional

K982723 - MAICO MA42

K982723 is an FDA 510(k) clearance for MAICO MA42, manufactured by Bernafon-Maico, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K982723 · Bernafon-Maico, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
84d
Days
Class 2
Risk

K982723 is an FDA 510(k) clearance for the MAICO MA42. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Bernafon-Maico, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bernafon-Maico, Inc. devices

FDA 510(k) Submission Details - K982723

510(k) Number K982723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date October 28, 1998
Days to Decision 84 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
6d faster than avg
Panel avg: 90d · This submission: 84d
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 K982723.
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
K983352 · Otodynamics, Ltd. · Dec 1998
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K983048 · American Electromedics Corp. · Nov 1998
EARSCAN 3
K982878 · Micro Audiometrics Corp. · Nov 1998
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
K982566 · Bar - Advanced Control Systems , Ltd. · Oct 1998
ECHO-SCREEN
K982642 · Fischer-Zoth Audiologic Systems, Inc. · Oct 1998
CCA-220
K982441 · Benson Medical Instruments Co. · Oct 1998