510(k) · Cleared
ClearedThermogard XP Thermal Regulation 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 Aug 23, 2007 after a 13-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 23, 2007
- Review
- 13 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK072234 Thermogard XP Thermal Regulation SystemAlsius Corp. · 2007
- 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
Most influential descendants
Showing 3 of 3 · See all- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K072234 | Thermogard XP Thermal Regulation System | Alsius Corp. | 2007 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 11.0 · 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 |
|---|---|---|---|
| * | — | Alsius CoolGard 3000/Alsius THERMOGARD thermal regulation system Named without a submission number | |
| * | — | Alsius THERMOGARD MT heat exchange system Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange… | 2021 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K213031 (Zoll Circulation, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Alsius THERMOGARD XP 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…
Read the full statement (252 words)
The Alsius THERMOGARD XP 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 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 - subarrachnoid hemorrhage).
Mortality by Diagnosis (ITT analysis)
Cool Line Control
n N % n N
CI 3 16 18.8 3 14 21.4 0.74
ICH 8 33 24.2 7 27 25.9 1.00
PTBI 10 44 22.7 4 38 10.5 0.24
SAH 13 61 21.3 7 63 11.1 0.15
*Fiscber's exact test
For more details on the clinical trial results please refer to Physician's Manual - "Normothermia for the Neuro-critically III stroke patient" #101416-001.
The Alsius THERMOGARD XP/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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072234: Thermogard XP Thermal Regulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072234
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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