Cleared Traditional

K982566 - AUTOMATIC SELF-OPERATED SCREENING AUDIO...

K982566 is an FDA 510(k) clearance for AUTOMATIC SELF-OPERATED SCREENING AUDIO..., manufactured by Bar - Advanced Control Systems , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982566 · Bar - Advanced Control Systems , Ltd. · Ear, Nose, Throat device
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Oct 1998
Decision
90d
Days
Class 2
Risk

K982566 is an FDA 510(k) clearance for the AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM). Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Bar - Advanced Control Systems , Ltd. (Ginot, Shomron, IL). The FDA issued a Cleared decision on October 21, 1998 after a review of 90 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 Bar - Advanced Control Systems , Ltd. devices

FDA 510(k) Submission Details - K982566

510(k) Number K982566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1998
Decision Date October 21, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 89d · This submission: 90d
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 K982566.
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