Cleared Traditional

K964646 - VIDEO EYE TRAKKER

K964646 is an FDA 510(k) clearance for VIDEO EYE TRAKKER, manufactured by Micromedical Technologies, Inc.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K964646 · Micromedical Technologies, Inc. · Neurology device
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Jul 1997
Decision
237d
Days
Class 2
Risk

K964646 is an FDA 510(k) clearance for the VIDEO EYE TRAKKER. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Micromedical Technologies, Inc. (Chatham, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 237 days - an extended review cycle.

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 Micromedical Technologies, Inc. devices

FDA 510(k) Submission Details - K964646

510(k) Number K964646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date July 15, 1997
Days to Decision 237 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 148d · This submission: 237d
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 K964646.
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · Ics Medical Corp. · Sep 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243 · Sensomotoric Instruments, GmbH · Sep 1997
VISUALEYES: VIDEO EYE MONITOR
K964325 · Micromedical Technologies, Inc. · Jul 1997
VARIOUS ELECTRODES
K941928 · Bio-Logic Systems Corp. · Feb 1995
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986