Cleared Traditional

K822268 - NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH

K822268 is an FDA 510(k) clearance for NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH, manufactured by Kelleher Corp.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K822268 · Kelleher Corp. · Neurology device
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Jan 1983
Decision
183d
Days
Class 2
Risk

K822268 is an FDA 510(k) clearance for the NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 183 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 Kelleher Corp. devices

FDA 510(k) Submission Details - K822268

510(k) Number K822268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date January 28, 1983
Days to Decision 183 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
35d slower than avg
Panel avg: 148d · This submission: 183d
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 42
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K822268.
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190 · Nicolet Biomedical Instruments · Nov 1985
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · Bio-Logic Systems Corp. · Jul 1985
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · Teca, Inc. · Dec 1984
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · Kelleher Corp. · Aug 1982
LIFE-TECH #5102 VISULAB
K812180 · Life-Tech Instruments, Inc. · Aug 1981