Cleared Traditional

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014241 · Alsius Corp. · Neurology device
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Aug 2003
Decision
583d
Days
Class 2
Risk

K014241 is an FDA 510(k) clearance for the COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D. 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 August 1, 2003 after a review of 583 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Alsius Corp. devices

Submission Details

510(k) Number K014241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 26, 2001
Decision Date August 01, 2003
Days to Decision 583 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
435d slower than avg
Panel avg: 148d · This submission: 583d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K014241.
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
K223746 · Zoll Circulation, Inc. · Jan 2023
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
K220008 · Zoll Circulation, Inc. · Jun 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
K213031 · Zoll Circulation, Inc. · Dec 2021