510(k) · Decided
Recalled · Class II · 2021Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Circulation, Inc. · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Oct 30, 2015 as substantially equivalent to K101987 (Zoll Circulation, 2010) and 1 other predicate after a 291-day review. Its family tree reaches back 7 generations to 1981. 3 of the 32 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 21 times.
- Decided
- Oct 30, 2015
- Review
- 291 days
- Class
- Class II
- Product code
- NCX
- Recalls
- 21
- Predicates
- 2
Its longest line of descent runs back 7 generations to K811742 (1981). 27 ancestors in all, the oldest K811743 (1981). 4 later devices descend from it, 2 citing it directly. 3 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 6 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 5 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
- 4 generations backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- 3 generations backK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
- 2 generations backK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
- 1 generation backK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
- This deviceK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK213031 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK220008 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223746 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · cites it directly3descendants
- K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2021 · cites it directly2descendants
- K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2022 · 2 generations on1descendant
- K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −6 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −5 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| −4 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| −3 | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | — |
| −2 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | — |
| −1 | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… | Zoll Circulation | 2010 | — |
| 0 (this device) | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY… | Zoll Circulation, Inc. | 2015 | — |
| +1 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016 | 4 |
| +1 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2021 | — |
| +2 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2022 | — |
| +2 | K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 2 | 0 |
| 1990 | 2 | 1 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 2 | 1 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NCX device
- #1 K213031 Solex 7 Intravascular Heat Exchange Catheter…score 10.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Summary page 6…Regulation: 21 CFR 870.5900, Thermal Regulating System Product Code: NCX Legally marketed devices to Cool Line Catheter Kit Model CL-2295A (K101987); ICY which substantial Catheter Kit Model IC-3893A (K101987); Quattro Catheter Kit equivalence is claimed: Model I… | 2010 |
| * | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DSummary page 6…C-3893A (K101987); Quattro Catheter Kit equivalence is claimed: Model IC-4593 (K101987); Start-Up Kit Model CG-500D and Model CG-500D EX (K014241) I. Device Description The ZOLL Intravascular Heat Exchange Catheters (Cool Line, ICY, and Quattro - ZOLL Catheters) are sterile… | 2003 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2021 | Class II | Z-0046-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0053-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0056-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0060-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0040-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0045-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0049-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0061-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0064-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0041-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0048-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0050-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0051-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0057-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0039-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0044-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0047-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0054-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0055-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0058-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Aug 6, 2021 | Class II | Z-0065-2022 | Labeling design | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
The 5 latest of 21 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 3 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 27 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K153226 (Zoll Circulation, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K101987.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NCX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NCX
204in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NCX
28in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NCX
273in 2025
MAUDE reports naming product code NCX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 28 | 2 | 4 |
| 2008 | 3 | 129 | 0 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 1 | — | 1 | 41 |
| 2015 | 1 | — | 0 | 32 |
| 2016 | 3 | 204 | 0 | 311 |
| 2017 | 0 | — | 0 | 450 |
| 2018 | 0 | — | 0 | 509 |
| 2019 | 0 | — | 0 | 436 |
| 2020 | 0 | — | 0 | 415 |
| 2021 | 1 | — | 28 | 461 |
| 2022 | 1 | — | 0 | 511 |
| 2023 | 1 | — | 0 | 373 |
| 2024 | 0 | — | 0 | 343 |
| 2025 | 0 | — | 0 | 273 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (309 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150046
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026