Cleared Traditional

K983851 - CAPELLA COCHLEAR EMISSIONS ANALYZER

K983851 is an FDA 510(k) clearance for CAPELLA COCHLEAR EMISSIONS ANALYZER, manufactured by Madsen Electronics, Inc.. 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.

K983851 · Madsen Electronics, Inc. · Ear, Nose, Throat device
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Jan 1999
Decision
90d
Days
Class 2
Risk

K983851 is an FDA 510(k) clearance for the CAPELLA COCHLEAR EMISSIONS ANALYZER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Madsen Electronics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on January 28, 1999 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 Madsen Electronics, Inc. devices

FDA 510(k) Submission Details - K983851

510(k) Number K983851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date January 28, 1999
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 K983851.
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