Cleared Special

K051448 - MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)

K051448 is an FDA 510(k) clearance for MODIFIED CONTACT-HEAT EVOKED POTENTIAL ..., manufactured by Medoc Ltd. Advanced Medical Systems. The device is a Class 2 Neurology device with product code NTU cleared through the Special 510(k) pathway after a 27-day FDA review.

K051448 · Medoc Ltd. Advanced Medical Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
27d
Days
Class 2
Risk

K051448 is an FDA 510(k) clearance for the MODIFIED 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 (Somerset, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 27 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051448

510(k) Number K051448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date June 29, 2005
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 149d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

NTU Device Classification - Class 2, Special Controls

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.

K051448 · MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
Download PDF FDA Summary Medoc Ltd. Advanced M…