Cleared Traditional

K992473 - EXPRESSEYE

K992473 is an FDA 510(k) clearance for EXPRESSEYE, manufactured by Optomotor Laboratories. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K992473 · Optomotor Laboratories · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
17d
Days
Class 2
Risk

K992473 is an FDA 510(k) clearance for the EXPRESSEYE. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Optomotor Laboratories (D-79104 Freiburg, DE). The FDA issued a Cleared decision on August 12, 1999 after a review of 17 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.

FDA 510(k) Submission Details - K992473

510(k) Number K992473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date August 12, 1999
Days to Decision 17 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 149d · This submission: 17d
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 59
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K992473.
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
K013060 · Ics Medical · Dec 2001
ENGPLUS
K010059 · Western Systems Research, Inc. · Feb 2001
EYETECT TREMOR MONITOR UNIT (TMU)
K003644 · Eyetect, LLC · Feb 2001
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
ULMER (VNG) VIDEO NYSTAGMOGRAPH
K982103 · Synapsys, Inc. · Sep 1998
K992473 · EXPRESSEYE
Download PDF FDA Summary Optomotor Laboratories