Cleared Special

K092373 - ICS CHARTR EP 200

K092373 is an FDA 510(k) clearance for ICS CHARTR EP 200, manufactured by Gn Otometrics. The device is a Class 2 Neurology device with product code GWJ cleared through the Special 510(k) pathway after a 29-day FDA review.

K092373 · Gn Otometrics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
29d
Days
Class 2
Risk

K092373 is an FDA 510(k) clearance for the ICS CHARTR EP 200. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Gn Otometrics (Deerfield, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - the FDA neurology 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 Gn Otometrics devices

FDA 510(k) Submission Details - K092373

510(k) Number K092373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date September 03, 2009
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 Neurology devices follow this clearance model.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 20
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K092373.
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