Cleared Traditional

K982103 - ULMER (VNG) VIDEO NYSTAGMOGRAPH

K982103 is an FDA 510(k) clearance for ULMER (VNG) VIDEO NYSTAGMOGRAPH, manufactured by Synapsys, Inc.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982103 · Synapsys, Inc. · Neurology device
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Sep 1998
Decision
88d
Days
Class 2
Risk

K982103 is an FDA 510(k) clearance for the ULMER (VNG) VIDEO NYSTAGMOGRAPH. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Synapsys, Inc. (Louisville, US). The FDA issued a Cleared decision on September 11, 1998 after a review of 88 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 Synapsys, Inc. devices

FDA 510(k) Submission Details - K982103

510(k) Number K982103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date September 11, 1998
Days to Decision 88 days
Submission Type Traditional
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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 31
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K982103.
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
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · Ics Medical Corp. · Sep 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243 · Sensomotoric Instruments, GmbH · Sep 1997
VISUALEYES: VIDEO EYE MONITOR
K964325 · Micromedical Technologies, Inc. · Jul 1997