510(k) · Cleared
Recalled · 2005Alsius Coolgard 3000 & Alsius Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alsius Corp. · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Oct 23, 2003 as substantially equivalent to K012512 (Radiant Medical, 2002) and 1 other predicate after a 255-day review. Its family tree reaches back 3 generations to 1981. 15 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 23, 2003
- Review
- 255 days
- Class
- Class II
- Product code
- NCX
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K811742 (1981). 14 ancestors in all, the oldest K811743 (1981). 15 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 2 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 1 generation backK022366 Celsius Control SystemInnercool Therapies · 2003
- This deviceK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003
- Descendant · cites it directly · 8 of its ownK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
- Descendant · 2 generations on · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
- Descendant · 2 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
- Descendant · cites it directly · 5 of its ownK081936 Solex Catheter, Model SL2593Alsius Corp. · 2008
- Descendant · 3 generations on · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005 · cites it directly8descendants
- K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · 2 generations on7descendants
- K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 2 generations on6descendants
- K081936Solex Catheter, Model SL2593Alsius Corp. · 2008 · cites it directly5descendants
- K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −2 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −1 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| 0 (this device) | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | — |
| +1 | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | — |
| +2 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | — |
| +2 | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… | Zoll Circulation | 2010 | — |
| +1 | K081936 | Solex Catheter, Model SL2593 | Alsius Corp. | 2008 | — |
| +3 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY… | Zoll Circulation, Inc. | 2015 | 21 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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.
Planning a device in NCX? 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.
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052443 | Icy Catheter, Model IC-3893A | 2005 | 8 |
| K081936 | Solex Catheter, Model SL2593 | 2008 | 5 |
| K033623 | Celsius Control System | 2004 | 2 |
| K071358 | Reprieve Endovascular Temperature Therapy System | 2007 | 0 |
| K051912 | Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A… | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K052443 (Alsius Corp., 2005) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K012512.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, is indicated for use: in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and, to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030421: Alsius Coolgard 3000 & Alsius Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030421
Report an extraction error
Are you the manufacturer?
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