Cleared Traditional

K863424 - COMPUTER EYE TRACKING SYS./ENG EXAM. CH...

K863424 is the FDA 510(k) clearance for COMPUTER EYE TRACKING SYS./ENG EXAM. CH... by Micromedical Technologies, Inc.. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K863424 · Micromedical Technologies, Inc. · Neurology device
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Mar 1987
Decision
200d
Days
Class 2
Risk

K863424 is an FDA 510(k) clearance for the COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Micromedical Technologies, Inc. (Auburn, US). The FDA issued a Cleared decision on March 23, 1987 after a review of 200 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

Submission Details

510(k) Number K863424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date March 23, 1987
Days to Decision 200 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 148d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K863424.
I-Portal Neuro Otologic Test Center
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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
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · Bio-Logic Systems Corp. · Jul 1985
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983