Cleared Traditional

K991497 - ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM

K991497 is an FDA 510(k) clearance for ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC S..., manufactured by Ics Medical Corp.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991497 · Ics Medical Corp. · Neurology device
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Jul 1999
Decision
90d
Days
Class 2
Risk

K991497 is an FDA 510(k) clearance for the ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on July 28, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ics Medical Corp. devices

FDA 510(k) Submission Details - K991497

510(k) Number K991497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1999
Decision Date July 28, 1999
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 46
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K991497.
BALANCEBACK VNG SYSTEM
K042529 · Fall Prevention Technologies, LLC · Oct 2004
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642 · Bertec Corp. · Aug 1999
ULMER (VNG) VIDEO NYSTAGMOGRAPH
K982103 · Synapsys, Inc. · Sep 1998
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · Ics Medical Corp. · Sep 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243 · Sensomotoric Instruments, GmbH · Sep 1997