Cleared Traditional

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) (K900096) - FDA 510(k) Clearance

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

K900096 · Artifical Hearing Systems Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
143d
Days
Class 2
Risk

K900096 is an FDA 510(k) clearance for the INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA). Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Artifical Hearing Systems Corp. (North Miami, US). The FDA issued a Cleared decision on May 31, 1990 after a review of 143 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Artifical Hearing Systems Corp. devices

Submission Details

510(k) Number K900096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1990
Decision Date May 31, 1990
Days to Decision 143 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
54d slower than avg
Panel avg: 89d · This submission: 143d
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.