Cleared Traditional

K905594 - NEUROFILE DATA STORAGE/ACCESORIES TO TH...

K905594 is an FDA 510(k) clearance for NEUROFILE DATA STORAGE/ACCESORIES TO TH..., manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWK cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K905594 · Nihon Kohden America, Inc. · Neurology device
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Jun 1991
Decision
197d
Days
Class 2
Risk

K905594 is an FDA 510(k) clearance for the NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 197 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1845 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K905594

510(k) Number K905594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date June 28, 1991
Days to Decision 197 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
49d slower than avg
Panel avg: 148d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWK Device Classification - Class 2, Special Controls

Product Code GWK Conditioner, Signal, Physiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1845
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 - GWK Conditioner, Signal, Physiological

All 9
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K905594.
ACTICAL
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ACTIHEART
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BIO-LOGIC BANKER
K872290 · Bio-Logic Systems Corp. · Oct 1987
BRAIN FUNCTION MAPPING OPTION FOR PATHF
K843598 · Nicolet Biomedical Instruments · Apr 1985
NEUROPACK 8 MEE 4108
K841497 · Nihon Kohden America, Inc. · Jun 1984