Cleared Traditional

K983051 - AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER

K983051 is an FDA 510(k) clearance for AMERICAN ELECTROMEDICS RACE CA TYMPANOM..., manufactured by American Electromedics Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K983051 · American Electromedics Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
78d
Days
Class 2
Risk

K983051 is an FDA 510(k) clearance for the AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by American Electromedics Corp. (Chico, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 78 days - a notably fast clearance cycle.

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: 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 American Electromedics Corp. devices

FDA 510(k) Submission Details - K983051

510(k) Number K983051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1998
Decision Date November 18, 1998
Days to Decision 78 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
12d faster than avg
Panel avg: 90d · This submission: 78d
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 K983051.
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K990652 · Idem (Int'L Dist. of Electronics For Medicine) · May 1999
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K983832 · Idem (Int'L Dist. of Electronics For Medicine) · Jan 1999
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
K983049 · American Electromedics Corp. · Nov 1998
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
K983046 · American Electromedics Corp. · Nov 1998
AMPLAID AM50
K974235 · Amplifon S.P.A. · Feb 1998
EARCHECK
K971859 · Mdi Instruments, Inc. · Aug 1997