Cleared Traditional

K894484 - AUDIOTESTER SCREENING AUDIOMETER

K894484 is an FDA 510(k) clearance for AUDIOTESTER SCREENING AUDIOMETER, manufactured by Prometex, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K894484 · Prometex, Inc. · Ear, Nose, Throat device
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Jun 1990
Decision
343d
Days
Class 2
Risk

K894484 is an FDA 510(k) clearance for the AUDIOTESTER SCREENING AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Prometex, Inc. (Houston, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Prometex, Inc. devices

FDA 510(k) Submission Details - K894484

510(k) Number K894484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date June 26, 1990
Days to Decision 343 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 89d · This submission: 343d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K894484.
MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · Qualitone · Oct 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · Starkey Laboratories, Inc. · Aug 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · Maico Hearing Instruments, Inc. · Jan 1990
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · Maico Hearing Instruments, Inc. · Oct 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · Maico Hearing Instruments, Inc. · Jun 1989