Cleared Traditional

K955289 - RACE CAR TYMPANOMETER

K955289 is an FDA 510(k) clearance for RACE CAR TYMPANOMETER, 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 22-day FDA review.

K955289 · American Electromedics Corp. · Ear, Nose, Throat device
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Dec 1995
Decision
22d
Days
Class 2
Risk

K955289 is an FDA 510(k) clearance for the RACE CAR TYMPANOMETER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by American Electromedics Corp. (Amherst, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 22 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 - K955289

510(k) Number K955289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date December 08, 1995
Days to Decision 22 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
68d faster than avg
Panel avg: 90d · This submission: 22d
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 K955289.
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