Cleared Traditional

K010059 - ENGPLUS

K010059 is the FDA 510(k) clearance for ENGPLUS by Western Systems Research, Inc.. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K010059 · Western Systems Research, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
50d
Days
Class 2
Risk

K010059 is an FDA 510(k) clearance for the ENGPLUS. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Western Systems Research, Inc. (Pasadena, US). The FDA issued a Cleared decision on February 27, 2001 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Western Systems Research, Inc. devices

Submission Details

510(k) Number K010059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date February 27, 2001
Days to Decision 50 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
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 K010059.
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I-Portal Neuro Otologic Test Center
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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