Cleared Traditional

K843598 - BRAIN FUNCTION MAPPING OPTION FOR PATHF

K843598 is an FDA 510(k) clearance for BRAIN FUNCTION MAPPING OPTION FOR PATHF, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Neurology device with product code GWK cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K843598 · Nicolet Biomedical Instruments · Neurology device
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Apr 1985
Decision
211d
Days
Class 2
Risk

K843598 is an FDA 510(k) clearance for the BRAIN FUNCTION MAPPING OPTION FOR PATHF. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 211 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 Nicolet Biomedical Instruments devices

FDA 510(k) Submission Details - K843598

510(k) Number K843598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date April 11, 1985
Days to Decision 211 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
63d slower than avg
Panel avg: 148d · This submission: 211d
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 12
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K843598.
MINI-LOGGER SERIES 2000
K991045 · Mini-Mitter Co., Inc. · Sep 1999
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594 · Nihon Kohden America, Inc. · Jun 1991
BIO-LOGIC BANKER
K872290 · Bio-Logic Systems Corp. · Oct 1987
NEUROPACK 8 MEE 4108
K841497 · Nihon Kohden America, Inc. · Jun 1984
NEUROTRAC
K841110 · Interspec, Inc. · Apr 1984
EVOKED RESPONSE STIMULATORS
K803226 · Bio-Logic Systems Corp. · Feb 1981