# K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D

- Pathway: 510(k) (Traditional)
- Applicant: Alsius Corp.
- Decided: Aug 1, 2003 after 583 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K820648 (1982). 8 ancestors in all.
11 later devices descend from it; 5 cite it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001520: Alpha Omega Dual Cooler-Heater, Alpha Omega, Inc. (2000)
- K001546: ALLON 2001, Mtre Advanced Technology, Ltd. (2000)
- K962577: Arrowgard Blue Quad-Lumen Central Venous Catheter, Arrow Intl., Inc. (1997) Summary page 2.
- K970864: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters, Arrow Intl., Inc. (1997) Summary page 2.

## Most influential descendants
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), 4 descendants of its own
- K141139: Solex Intravascular Heat Exchange Catheter (2014), 4 descendants of its own
- K153226: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (2016), 3 descendants of its own
- K213031: 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 (2021), 2 descendants of its own

## Recalls of this device
- Jan 1, 2007 · Not classified · Z-0502-2007: Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
- Jan 1, 2007 · Not classified · Z-0503-2007: Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
- Nov 9, 2005 · Not classified · Z-0369-06: Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
- Jul 25, 2005 · Not classified · Z-1397-05: Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.
- Nov 10, 2004 · Not classified · Z-0258-05: Product alarms that there may be a power supply interruption.
- Jun 21, 2004 · Not classified · Z-1159-04: Higher than expected rate of pump alarms occur under specific conditions.

## Indications for use
The Alsius CoolGardB 3000 and Cool Line Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

Source page: https://510kreport.com/device/K014241
Methodology: https://510kreport.com/methodology