Cleared Abbreviated

K991642 - EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX

K991642 is an FDA 510(k) clearance for EYE TRAK TM, manufactured by Bertec Corp.. The device is a Class 2 Neurology device with product code GWN cleared through the Abbreviated 510(k) pathway after a 82-day FDA review.

K991642 · Bertec Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
82d
Days
Class 2
Risk

K991642 is an FDA 510(k) clearance for the EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Bertec Corp. (Columbus, US). The FDA issued a Cleared decision on August 3, 1999 after a review of 82 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bertec Corp. devices

FDA 510(k) Submission Details - K991642

510(k) Number K991642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1999
Decision Date August 03, 1999
Days to Decision 82 days
Submission Type Abbreviated
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
66d faster than avg
Panel avg: 148d · This submission: 82d
Pathway characteristics
Standards-based clearance path.

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 31
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K991642.
EYESEECAM VHIT
K131681 · Interacoustics A/S · Sep 2013
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497 · Ics Medical Corp. · Jul 1999
ULMER (VNG) VIDEO NYSTAGMOGRAPH
K982103 · Synapsys, Inc. · Sep 1998
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · Ics Medical Corp. · Sep 1997