510(k) · Decided

Recalled · 2007

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

K014241510(k) TraditionalDecided Aug 1, 2003583-day reviewClass II21 CFR 870.5900Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alsius Corp. · NCX System, Hypothermia, Intravenous, Cooling

Cleared on Aug 1, 2003 as substantially equivalent to K001520 (Alpha Omega, Inc., 2000) and 3 other predicates after a 583-day review. Its family tree reaches back 2 generations to 1982. 3 of the 20 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 6 times.

Decided: Aug 1, 2003
Review: 583 days
Class: Class II
Product code: NCX
Recalls: 6
Predicates: 4

Its longest line of descent runs back 2 generations to K820648 (1982). 8 ancestors in all. 11 later devices descend from it, 5 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK820648 Arrow M.I.S. Multi-Lumen CatheterizaArrow Intl., Inc. · 1982 · Recalled
1 generation backK970864 Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Recalled (Class I)
This deviceK014241 Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A…Alsius Corp. · 2003
Descendant · cites it directly · 6 of its ownK101987 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 · 2 generations on · 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

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004high 2 (2016) · low 0 (2006)2026

Class I recalls in this family

K970864 Arrow-Howes Large Bore Multi-Lumen Central…direct predicate · 1997
K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kit2 generations back · 1990
K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip2 generations back · 1986

Most influential descendants

Showing 5 of 11 · See all

K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · cites it directly6descendants
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 · 2 generations on4descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K820648	Arrow M.I.S. Multi-Lumen Catheteriza	Arrow Intl., Inc.	1982	7
−1	K970864	Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters	Arrow Intl., Inc.	1997	Class I
0 (this device)	K014241	Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D	Alsius Corp.	2003	—
+1	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
+2	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1986	1	1
1990	1	1
1997	1	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2008	1	0
2010	1	0
2014	1	0
2015	1	0
2016	2	0
2021	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K014241, 1982–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	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 Summary page 2 …OOl 546; S.E. 06-08-2000 ARROWgard Blue Quad-Lumen Central Venous Catheter Arrow International, Inc., Reading PA K962577; S.E. 08-21-1997 Arrow-Howes Large Bore Multi Lumen central venous catheter Arrow Internati…	Arrow Intl., Inc.	1997	1
*	K970864	Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters Summary page 2 …S.E. 08-21-1997 Arrow-Howes Large Bore Multi Lumen central venous catheter Arrow International, Inc., Reading PA K970864; S.E. 09-17-1997 indications for Use The Alsius CoolGard@3000 and Cool Line TM Catheter Thermal Regulation System is…	Arrow Intl., Inc.	1997	Class I

Also cleared against K001520: 1 other device →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101987	Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…	Zoll Circulation	2010	6
K150046	Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…	Zoll Circulation, Inc.	2015	4
K153226	Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit	Zoll Circulation, Inc.	2016	3
K033623	Celsius Control System	Innercool Therapies, Inc.	2004	2
K051912	Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…	Alsius Corp.	2005	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 1, 2007	Not classified	Z-0502-2007	Other	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	Other	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	Other	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	Other	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	Other	Product alarms that there may be a power supply interruption.
Jun 21, 2004	Not classified	Z-1159-04	Other	Higher than expected rate of pump alarms occur under specific conditions.

The 5 latest of 6 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 2 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 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
5 of the 8 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K101987 (Zoll Circulation, 2010) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K001520.

How does its category compare?

All NCX devices

NCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCX

1in 2023

2007high 6 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NCX

204in 2016

2007high 204 (2016) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NCX

28in 2021

2007high 28 (2021) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NCX

273in 2025

2007high 511 (2022) · low 4 (2007)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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014241

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026