Pathfinder Electrodiagnostic System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K801604 ↗

FDA Product Code

GWK

Device Class

Class II

Regulation

21 CFR Part 882.1845

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• EMG Surface, Digital Ring, Bar, Grounding, EEG

  Class II

  FDA 510(k) K850108 Active Cleared 11 Apr 1985

• Nicolet Viking

  Class II

  FDA 510(k) K842956 Active Cleared 3 Aug 1984

• Nic-200 Ventricular Function Analyzer

  Class I

  FDA 510(k) K792466 Active Cleared 24 Jan 1980

• Arteoial Tonometer Ml-105

  Class II

  FDA 510(k) K771449 Active Cleared 6 Sep 1977

• Compact Visual

  Class II

  FDA 510(k) K842613 Active Cleared 20 Jul 1984

• Brain Function Mapping Option for Pathf

  Class II

  FDA 510(k) K843598 Active Cleared 11 Apr 1985

See all devices from Nicolet Biomedical Instruments →

• What types of neurological and neuromuscular conditions can the Pathfinder Electrodiagnostic System help assess?

  The Pathfinder Electrodiagnostic System is designed to process and amplify electrical signals from nerve and muscle evaluations, which aids in assessing neurological and neuromuscular conditions. This includes testing for peripheral neuropathies, muscle disorders, and other nerve-related dysfunctions, though the exact conditions depend on clinical interpretation of the amplified signals.

• Is the Pathfinder Electrodiagnostic System intended for single-use or reusable clinical settings?

  The Pathfinder Electrodiagnostic System is explicitly supplied as a reusable medical instrument, meaning it is built for repeated use in clinical environments after proper cleaning and maintenance. It is not intended for single-use applications.

• What regulatory pathway was followed for FDA clearance of the Pathfinder Electrodiagnostic System?

  The Pathfinder Electrodiagnostic System received FDA clearance through a 510(k) premarket notification process under the traditional review pathway. It was determined to be substantially equivalent to a legally marketed predicate device, with clearance granted on August 4, 1980 (K801604). The device falls under product code GWK and is classified as a Class II medical device under special controls.

• Does the Pathfinder Electrodiagnostic System require any special handling for sterility or MRI safety?

  The provided data does not specify any sterility requirements for the Pathfinder Electrodiagnostic System, as it is a reusable instrument. Additionally, there is no mention of MRI safety information, so users should confirm compatibility with their facility’s MRI protocols before use in such environments.