Cleared Traditional

COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A (K051912) - FDA 510(k) Clearance

Also marketed or referenced as:
ICY CATHETER KIT, MODEL IC-3585A FORTIUS CATHETER KIT, MOD. FR-5093B

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

K051912 · Alsius Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
89d
Days
Class 2
Risk

K051912 is an FDA 510(k) clearance for the COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A. 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 October 11, 2005 after a review of 89 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.

View all Alsius Corp. devices

Submission Details

510(k) Number K051912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 14, 2005
Decision Date October 11, 2005
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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 K051912.
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