Cleared Traditional

K060308 - COOLGARD 3000

K060308 is an FDA 510(k) clearance for COOLGARD 3000, manufactured by Alsius Corp.. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K060308 · Alsius Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
78d
Days
Class 2
Risk

K060308 is an FDA 510(k) clearance for the COOLGARD 3000. 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 April 26, 2006 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060308

510(k) Number K060308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 07, 2006
Decision Date April 26, 2006
Days to Decision 78 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
71d faster than avg
Panel avg: 149d · This submission: 78d
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 25
Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K060308.
QUATTRO CATHETER MODEL IC4593
K070161 · Alsius Corp. · Feb 2007
THERMOGARD THERMAL REGULATION SYSTEM
K063829 · Alsius Corp. · Jan 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K063405 · Radiant Medical · Jan 2007
ICY CATHETER, MODEL IC-3893A
K052443 · Alsius Corp. · Oct 2005
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A
K051912 · Alsius Corp. · Oct 2005
CELSIUS CONTROL SYSTEM
K033623 · Innercool Therapies, Inc. · May 2004
K060308 · COOLGARD 3000
Download PDF FDA Summary Alsius Corp.