Cleared Traditional

K871466 - VESTIBULAR AUTOROTATION TEST

K871466 is the FDA 510(k) clearance for VESTIBULAR AUTOROTATION TEST by Western Systems Research, Inc.. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K871466 · Western Systems Research, Inc. · Neurology device
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Jul 1987
Decision
101d
Days
Class 2
Risk

K871466 is an FDA 510(k) clearance for the VESTIBULAR AUTOROTATION TEST. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Western Systems Research, Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 24, 1987 after a review of 101 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 Western Systems Research, Inc. devices

Submission Details

510(k) Number K871466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1987
Decision Date July 24, 1987
Days to Decision 101 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 148d · This submission: 101d
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 K871466.
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ELECTRONYSTAGMOGRAPH (ENG RECORDER)
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NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983