Cleared Special

K063405 - REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

K063405 is an FDA 510(k) clearance for REPRIEVE ENDOVASCULAR TEMPERATURE THERA..., manufactured by Radiant Medical. The device is a Class 2 Neurology device with product code NCX cleared through the Special 510(k) pathway after a 60-day FDA review.

K063405 · Radiant Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
60d
Days
Class 2
Risk

K063405 is an FDA 510(k) clearance for the REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Radiant Medical (Redwood City, US). The FDA issued a Cleared decision on January 8, 2007 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.5900 - 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 - K063405

510(k) Number K063405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date January 08, 2007
Days to Decision 60 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
89d faster than avg
Panel avg: 149d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

NCX Device Classification - Class 2, Special Controls

Product Code NCX System, Hypothermia, Intravenous, Cooling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
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.

Regulatory Peers - NCX System, Hypothermia, Intravenous, Cooling

All 25
Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K063405.
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K051912 · Alsius Corp. · Oct 2005
K063405 · REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
Download PDF FDA Summary Radiant Medical