Cleared Special

K063829 - THERMOGARD THERMAL REGULATION SYSTEM

K063829 is an FDA 510(k) clearance for THERMOGARD THERMAL REGULATION SYSTEM, manufactured by Alsius Corp.. The device is a Class 2 Neurology device with product code NCX cleared through the Special 510(k) pathway after a 27-day FDA review.

K063829 · Alsius Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
27d
Days
Class 2
Risk

K063829 is an FDA 510(k) clearance for the THERMOGARD THERMAL REGULATION SYSTEM. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Alsius Corp. (Irvine, US). The FDA issued a Cleared decision on January 22, 2007 after a review of 27 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 - K063829

510(k) Number K063829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 26, 2006
Decision Date January 22, 2007
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.

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 K063829.
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K063829 · THERMOGARD THERMAL REGULATION SYSTEM
Download PDF FDA Summary Alsius Corp.