Cleared Traditional

K013060 - ICS MEDICAL MODEL VG-30 VIDEO GOGGLES

K013060 is an FDA 510(k) clearance for ICS MEDICAL MODEL VG-30 VIDEO GOGGLES, manufactured by Ics Medical. 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.

K013060 · Ics Medical · Neurology device
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Dec 2001
Decision
90d
Days
Class 2
Risk

K013060 is an FDA 510(k) clearance for the ICS MEDICAL MODEL VG-30 VIDEO GOGGLES. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Ics Medical (Schaumburg, US). The FDA issued a Cleared decision on December 10, 2001 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 devices

FDA 510(k) Submission Details - K013060

510(k) Number K013060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2001
Decision Date December 10, 2001
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
59d faster than avg
Panel avg: 149d · 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 50
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K013060.
FOCUS VNG/ENG TYPE 1068
K061791 · Gn Otometrics A/S · Jul 2006
DDAT OMT
K050098 · Ddat(Uk), Ltd. · May 2005
BALANCEBACK VNG SYSTEM
K042529 · Fall Prevention Technologies, LLC · Oct 2004
ENGPLUS
K010059 · Western Systems Research, Inc. · Feb 2001
EYETECT TREMOR MONITOR UNIT (TMU)
K003644 · Eyetect, LLC · Feb 2001
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999