510(k) · Decided
DecidedCool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Circulation · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Oct 12, 2010 as substantially equivalent to K014241 (Alsius Corp., 2003) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1981. 3 of the 33 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Oct 12, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K811742 (1981). 26 ancestors in all, the oldest K811743 (1981). 6 later devices descend from it, 3 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 5 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 4 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
- 3 generations backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- 2 generations backK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
- 1 generation backK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
- This deviceK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
- Descendant · cites it directly · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK141139 Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014
- Descendant · cites it directly · 3 of its ownK153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK213031 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK220008 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc. · 2015 · cites it directly4descendants
- K141139Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014 · cites it directly4descendants
- 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 · 2 generations on2descendants
- K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −5 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −4 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| −3 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| −2 | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | — |
| −1 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | — |
| 0 (this device) | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… | Zoll Circulation | 2010 | — |
| +1 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY… | Zoll Circulation, Inc. | 2015 | 21 |
| +1 | K141139 | Solex Intravascular Heat Exchange Catheter | Zoll Circulation | 2014 | — |
| +1 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016 | 4 |
| +2 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2021 | — |
| +3 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2022 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D | 2003 |
| * | K052443 | Icy Catheter, Model IC-3893ASummary page 6…me 510(k) # | Decision Date | Decision Cool Line Catheter Kit Model | KO14241 08/01/2003 Substantially equivalent — with CL-2295A limitations (SU) lcy Catheter Kit Model K052443 10/17/2006 Substantially equivalent (SE) IC-3893A Quattro Catheter Kit Model K070161 02/15/2007 Substantially equivalent (SE) IC-… | 2005 |
| * | K070161 | Quattro Catheter Model IC4593Summary page 6…003 Substantially equivalent — with CL-2295A limitations (SU) lcy Catheter Kit Model K052443 10/17/2006 Substantially equivalent (SE) IC-3893A Quattro Catheter Kit Model K070161 02/15/2007 Substantially equivalent (SE) IC-4593 650 Almanor Avenue Page 25 Tel: 408.541.2140 Sunnyvale, California 94085 Fax:… | 2007 |
What descends from it? (6)
3 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)
No FDA recall names this device.
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 29 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 26 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K150046 (Zoll Circulation, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K014241.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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. The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use: + In cardiac surgery…
Read the full statement (152 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.
The ZOLL ICY Catheter Model IC-3893A, connected to the 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 ZOLL Quattro Catheter Mode! 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.
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/K101987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101987
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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