Cleared Traditional

K002985 - ICS MEDICAL CHARTR EP AND CHARTR OAE SY...

K002985 is the FDA 510(k) clearance for ICS MEDICAL CHARTR EP AND CHARTR OAE SY... by Ics Medical Corp.. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K002985 · Ics Medical Corp. · Neurology device
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Dec 2000
Decision
79d
Days
Class 2
Risk

K002985 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on December 13, 2000 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ics Medical Corp. devices

Submission Details

510(k) Number K002985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date December 13, 2000
Days to Decision 79 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K002985.
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