# K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation, Inc.
- Decided: Oct 30, 2015 after 291 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K811742 (1981). 27 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593, Zoll Circulation (2010) Summary page 6.
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D, Alsius Corp. (2003) Summary page 6.

## Most influential descendants
- 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
- K220008: 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 (2022), 1 descendant of its own
- K223746: 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 (2023), 0 descendants of its own

## Recalls of this device
- Aug 6, 2021 · Class II · Z-0046-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0053-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0056-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0060-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0040-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0045-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0049-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0061-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0064-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0041-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0048-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0050-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0051-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0057-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0039-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0044-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0047-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0054-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0055-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0058-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Aug 6, 2021 · Class II · Z-0065-2022: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

## Indications for use
The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. WARNING - Fever Reduction The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI — cerebral infarction, ICH — intracerebral hemorrhage, PTBI — primary traumatic brain injury, SAH — subarachnoid hemorrhage). Mortality by Diagnosis (ITT analysis) *Fischer’s exact test For more details on the clinical trial results please refer to Physician’s Manual — “Normothermia for the Neuro-critically Ill stroke patient” PN 8700-0634-01. The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893-A, connected to the ZOLL CoolGard 3000/Thermogard XP Thermal Regulation System, is indicated for use: * In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and * To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: * In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and * To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The Start-Up Kit (SUK) is intended to control patient core temperature using heat exchange fluid in conjunction with CoolGard 3000 or Thermogard XP system and ZOLL Heat Exchange Catheters, but does not have a specific independent indications for use.

Source page: https://510kreport.com/device/K150046
Methodology: https://510kreport.com/methodology