Cleared Traditional

K850180 - ELECTRONYSTAGMOGRAPH (ENG RECORDER)

K850180 is an FDA 510(k) clearance for ELECTRONYSTAGMOGRAPH (ENG RECORDER), manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K850180 · Bio-Logic Systems Corp. · Neurology device
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Jul 1985
Decision
186d
Days
Class 2
Risk

K850180 is an FDA 510(k) clearance for the ELECTRONYSTAGMOGRAPH (ENG RECORDER). Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Northbrook, US). The FDA issued a Cleared decision on July 22, 1985 after a review of 186 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K850180

510(k) Number K850180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1985
Decision Date July 22, 1985
Days to Decision 186 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
38d slower than avg
Panel avg: 148d · This submission: 186d
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 17
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K850180.
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190 · Nicolet Biomedical Instruments · Nov 1985
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · Teca, Inc. · Dec 1984
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · Kelleher Corp. · Aug 1982