Cleared Traditional

CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) (K041908) - FDA 510(k) Clearance

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

K041908 · Medoc Ltd. Advanced Medical Systems · Neurology device
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Feb 2005
Decision
225d
Days
Class 2
Risk

K041908 is an FDA 510(k) clearance for the CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS). Classified as Evoked Potential Stimulator, Thermal (product code NTU), Class II - Special Controls.

Submitted by Medoc Ltd. Advanced Medical Systems (Minneapolis, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 225 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Medoc Ltd. Advanced Medical Systems devices

Submission Details

510(k) Number K041908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2004
Decision Date February 25, 2005
Days to Decision 225 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 148d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.