510(k) · Decided
DecidedCool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A; Fortius Catheter Kit, Mod. FR-5093B
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 11, 2005 as substantially equivalent to K030421 (Alsius Corp., 2003) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1981. 3 of the 25 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 11, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K811742 (1981). 24 ancestors in all, the oldest K811743 (1981). No later device cites it as a predicate yet. 3 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 3 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 2 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
- 1 generation backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- This deviceK051912 Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit…Alsius Corp. · 2005
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −3 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −2 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| −1 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| 0 (this device) | K051912 | Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model… | Alsius Corp. | 2005 | — |
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 |
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 |
|---|---|---|---|
| * | K030421 | Alsius Coolgard 3000 & Alsius Catheter SystemSummary page 3…cy® and Fortius®M Catheters in an MRI environment. The predicate devices for this change in labeling are the catheters themselves as cleared under the following 510O(k): K030421 (Fortius and ICY) and K014241 (Cool Line). The labeling of these catheters is otherwise unchanged. Conclusion In summary, descrip… | 2003 |
| * | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DSummary page 3…an MRI environment. The predicate devices for this change in labeling are the catheters themselves as cleared under the following 510O(k): K030421 (Fortius and ICY) and K014241 (Cool Line). The labeling of these catheters is otherwise unchanged. Conclusion In summary, descriptive information and performan… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- 4 other devices also cite its predicate K030421.
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 TM 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM or FortiusTM 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. The Alsius CoolGard® 3000 and Cool Line TM Catheter Thermal Regulation System is…
Read the full statement (204 words)
The COOLGARD TM 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM or FortiusTM 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.
The Alsius CoolGard® 3000 and Cool Line TM 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.
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The modtality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (Cl - cerebral infarction, ICH - intracerebral hemorrhage, PIBI - primary traumatic brain injury, SAH - subarrachnoid hemorrhage).
For more details on the clinical trial results please refer to Physician's Manual - "Normothermia for the Neuro-critically Ill stroke patient" #101416-001.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051912 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051912: Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A; Fortius Catheter Kit, Mod. FR-5093B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051912
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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