Cleared Traditional

K894484 - AUDIOTESTER SCREENING AUDIOMETER (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894484 · Prometex, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.