Cleared Traditional

PATHFINDER ELECTRODIAGNOSTIC SYSTEM (K801604) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801604 · Nicolet Biomedical Instruments · Neurology device
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Aug 1980
Decision
21d
Days
Class 2
Risk

K801604 is an FDA 510(k) clearance for the PATHFINDER ELECTRODIAGNOSTIC SYSTEM. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K801604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1980
Decision Date August 04, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 148d · This submission: 21d
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.