Cleared Traditional

K982878 - EARSCAN 3

K982878 is an FDA 510(k) clearance for EARSCAN 3, manufactured by Micro Audiometrics Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K982878 · Micro Audiometrics Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
81d
Days
Class 2
Risk

K982878 is an FDA 510(k) clearance for the EARSCAN 3. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Micro Audiometrics Corp. (South Daytona, US). The FDA issued a Cleared decision on November 3, 1998 after a review of 81 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 Micro Audiometrics Corp. devices

FDA 510(k) Submission Details - K982878

510(k) Number K982878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1998
Decision Date November 03, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 90d · This submission: 81d
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 K982878.
ILO292 DP ECHOPORT PLUS OAE SYSTEM
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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
MAICO MA42
K982723 · Bernafon-Maico, Inc. · Oct 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