510(k) · Cleared
Recalled · Class II · 2014Innercool Therapies, Inc., Rapidblue System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innercool Therapies, Inc.- A Delaware Corporation · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Oct 17, 2008 as substantially equivalent to K033623 (Innercool Therapies, Inc., 2004) after a 199-day review. Its family tree reaches back 5 generations to 1981. 3 of the 27 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 17, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- NCX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K811742 (1981). 25 ancestors in all, the oldest K811743 (1981). 1 later device descends from it, 1 citing it directly. 3 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 4 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 3 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
- 2 generations backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- 1 generation backK033623 Celsius Control SystemInnercool Therapies, Inc. · 2004
- This deviceK080908 Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation · 2008
- Descendant · cites it directly · 0 of its ownK152946 TempedySeiratherm GmbH · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K152946TempedySeiratherm GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −4 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −3 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| −2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| −1 | K033623 | Celsius Control System | Innercool Therapies, Inc. | 2004 | — |
| 0 (this device) | K080908 | Innercool Therapies, Inc., Rapidblue System | Innercool Therapies, Inc.- A Delaware Corporation | 2008 | — |
| +1 | 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 |
|---|---|---|
| 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 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? (1)
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 |
|---|---|---|---|
| * | K033623 | Celsius Control SystemSummary page 1…mal Regulating System Predicate Devices The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by INNERCOOL therapies (K033623). Device Description The subject device is a thermal regulating system consisting of three (3) parts: 1. A console contain… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152946 | Tempedy | 2016 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2014 | Class II | Z-0845-2014 | Nonconforming Material/Component | Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm. |
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 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 4 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 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 13 of the 25 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K152946 (Seiratherm GmbH, 2016) has gone furthest, with 0 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. 2008, 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 RapidBlue TM 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/K080908 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080908: Innercool Therapies, Inc., Rapidblue System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080908
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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