Cleared Traditional

K010059 - ENGPLUS

K010059 is an FDA 510(k) clearance for ENGPLUS, manufactured by Western Systems Research, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K010059

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.

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 47
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K010059.
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
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642 · Bertec Corp. · Aug 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497 · Ics Medical Corp. · Jul 1999