Cleared Traditional

K080899 - ARCTIC BLAST INTRAVENOUS FLUID CHILLER

K080899 is an FDA 510(k) clearance for ARCTIC BLAST INTRAVENOUS FLUID CHILLER, manufactured by Medivance, Inc.. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K080899 · Medivance, Inc. · Neurology device
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Aug 2008
Decision
129d
Days
Class 2
Risk

K080899 is an FDA 510(k) clearance for the ARCTIC BLAST INTRAVENOUS FLUID CHILLER. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.5900 - 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 Medivance, Inc. devices

FDA 510(k) Submission Details - K080899

510(k) Number K080899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date August 07, 2008
Days to Decision 129 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 149d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 22
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