Cleared Traditional

K843598 - BRAIN FUNCTION MAPPING OPTION FOR PATHF

K843598 is the FDA 510(k) clearance for BRAIN FUNCTION MAPPING OPTION FOR PATHF by Nicolet Biomedical Instruments. It is a Class 2 Neurology device (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

Submission Details

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
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.

Device Classification

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 7
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K843598.
ACTIHEART
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NEUROPACK 8 MEE 4108
K841497 · Nihon Kohden America, Inc. · Jun 1984
EVOKED RESPONSE STIMULATORS
K803226 · Bio-Logic Systems Corp. · Feb 1981