Cleared Special

PATHWAY - ATS/CHEPS (K052357) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052357 · Medoc Ltd. Advanced Medical Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
143d
Days
Class 2
Risk

K052357 is an FDA 510(k) clearance for the PATHWAY - ATS/CHEPS. Classified as Evoked Potential Stimulator, Thermal (product code NTU), Class II - Special Controls.

Submitted by Medoc Ltd. Advanced Medical Systems (Somerset, US). The FDA issued a Cleared decision on January 19, 2006 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medoc Ltd. Advanced Medical Systems devices

Submission Details

510(k) Number K052357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date January 19, 2006
Days to Decision 143 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NTU Evoked Potential Stimulator, Thermal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
Definition Intended To Evaluate The Functionality Of Human Pain Reception And Transmission Of Sensory Pathways
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.