Cleared Traditional

K851190 - NYSTAGMOGRAPH EOG/ENG ANALYSES

K851190 is an FDA 510(k) clearance for NYSTAGMOGRAPH EOG/ENG ANALYSES, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K851190 · Nicolet Biomedical Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
246d
Days
Class 2
Risk

K851190 is an FDA 510(k) clearance for the NYSTAGMOGRAPH EOG/ENG ANALYSES. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on November 27, 1985 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nicolet Biomedical Instruments devices

FDA 510(k) Submission Details - K851190

510(k) Number K851190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date November 27, 1985
Days to Decision 246 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 148d · This submission: 246d
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 44
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K851190.
VARIOUS ELECTRODES
K941928 · Bio-Logic Systems Corp. · Feb 1995
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · Bio-Logic Systems Corp. · Jul 1985
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · Teca, Inc. · Dec 1984
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983