Cleared Traditional

K002985 - ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS

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

K002985 · Ics Medical Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K002985

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 149d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 75
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K002985.
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K993177 · Sle Limited · Nov 1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K991853 · Idem (Int'L Dist. of Electronics For Medicine) · Oct 1999
K002985 · ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
Download PDF FDA Summary Ics Medical Corp.