510(k) · Cleared
ClearedCelsius Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innercool Therapies, Inc. · NCX System, Hypothermia, Intravenous, Cooling
Cleared on May 21, 2004 as substantially equivalent to K012512 (Radiant Medical, 2002) and 2 other predicates after a 185-day review. Its family tree reaches back 4 generations to 1981. 3 of the 27 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- May 21, 2004
- Review
- 185 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K811742 (1981). 24 ancestors in all, the oldest K811743 (1981). 2 later devices descend from it, 1 citing it directly. 3 of the 27 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 deviceK033623 Celsius Control SystemInnercool Therapies, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK080908 Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK152946 TempedySeiratherm GmbH · 2016
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView 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) | K033623 | Celsius Control System | Innercool Therapies, Inc. | 2004 | — |
| +1 | K080908 | Innercool Therapies, Inc., Rapidblue System | Innercool Therapies, Inc.- A Delaware Corporation | 2008 | 1 |
| +2 | K152946 | Tempedy | Seiratherm GmbH | 2016 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K012512 | Setpoint Endovascular Temperature Management SystemSummary page 1…g System Predicate Devices The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by Radiant Medical (K012512), and Alsius (K014241, K030421). Device Description The subject device is a thermal regulating system consis… | 2002 |
| * | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DSummary page 1…ate Devices The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by Radiant Medical (K012512), and Alsius (K014241, K030421). Device Description The subject device is a thermal regulating system consisting of three (3) part… | 2003 |
| * | K030421 | Alsius Coolgard 3000 & Alsius Catheter SystemSummary page 1…The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by Radiant Medical (K012512), and Alsius (K014241, K030421). Device Description The subject device is a thermal regulating system consisting of three (3) parts: a… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080908 | Innercool Therapies, Inc., Rapidblue System | 2008 | 1 |
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 23 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 13 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K080908 (Innercool Therapies, Inc.- A Delaware Corporation, 2008) has gone furthest, with 1 descendant 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 Celsius ControlTM System is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care, to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who required 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/K033623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033623: Celsius Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033623
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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