Cleared Special

ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS (K031986) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031986 · Ics Medical · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
27d
Days
Class 2
Risk

K031986 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Ics Medical (Schaumburg, US). The FDA issued a Cleared decision on July 24, 2003 after a review of 27 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ics Medical devices

Submission Details

510(k) Number K031986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date July 24, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 89d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - EWO Audiometer

All 234
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K031986.
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Lyra
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