Cleared Traditional

K972243 - 2D VOG - VIDEO-OCULOGRAPHY

K972243 is an FDA 510(k) clearance for 2D VOG - VIDEO-OCULOGRAPHY, manufactured by Sensomotoric Instruments, GmbH. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972243 · Sensomotoric Instruments, GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
86d
Days
Class 2
Risk

K972243 is an FDA 510(k) clearance for the 2D VOG - VIDEO-OCULOGRAPHY. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Sensomotoric Instruments, GmbH (Teltow, DE). The FDA issued a Cleared decision on September 10, 1997 after a review of 86 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 Sensomotoric Instruments, GmbH devices

FDA 510(k) Submission Details - K972243

510(k) Number K972243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date September 10, 1997
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 K972243.
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
VISUALEYES: VIDEO EYE MONITOR
K964325 · Micromedical Technologies, Inc. · Jul 1997
VIDEO EYE TRAKKER
K964646 · Micromedical Technologies, Inc. · Jul 1997
VARIOUS ELECTRODES
K941928 · Bio-Logic Systems Corp. · Feb 1995