Cleared Special

K080908 - INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

K080908 is an FDA 510(k) clearance for INNERCOOL THERAPIES, manufactured by Innercool Therapies, Inc.- A Delaware Corporation. The device is a Class 2 Neurology device with product code NCX cleared through the Special 510(k) pathway after a 199-day FDA review.

K080908 · Innercool Therapies, Inc.- A Delaware Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
199d
Days
Class 2
Risk

K080908 is an FDA 510(k) clearance for the INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Innercool Therapies, Inc.- A Delaware Corporation (San Diego, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 199 days - an extended review 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. Standard predicate reliance. 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 - K080908

510(k) Number K080908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date October 17, 2008
Days to Decision 199 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
50d slower than avg
Panel avg: 149d · This submission: 199d
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
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K080908 · INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
Download PDF FDA Summary Innercool Therapies, …