510(k) Report

510(k) · Cleared

Cleared

Celsius Control System

K022366510(k) TraditionalCleared Jan 27, 2003189-day reviewClass II21 CFR 870.5900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Innercool Therapies · NCX System, Hypothermia, Intravenous, Cooling

Cleared on Jan 27, 2003 as substantially equivalent to K002577 (Medivance, Inc., 2000) and 5 other predicates after a 189-day review. Its family tree reaches back 2 generations to 1981. 16 later devices descend from it.

Decided
Jan 27, 2003
Review
189 days
Class
Class II
Product code
NCX
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K811742 (1981). 13 ancestors in all, the oldest K811743 (1981). 16 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 3 other ancestors1991: 2 other ancestors1990: 1 other ancestor1981: 1 other ancestor2001: 1 other ancestor1993: 1 other ancestor1989: 2 other ancestors2007: 2 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2008: 2 descendants cleared2004: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2015: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant clearedK811742 · Hemotherm Model 400 · Cincinnati Sub-Zero · 1981 · recalledK012512 · Setpoint Endovascular Temperature Management System · Radiant Medical · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 6 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants K012512 · Setpoint Endovascular Temperature Management System · Radiant Medical · 2002K811742 · Hemotherm Model 400 · Cincinnati Sub-Zero · 1981 · recalled0+5
  1. Root · 2 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
  2. 1 generation backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
  3. This deviceK022366 Celsius Control SystemInnercool Therapies · 2003
  4. Descendant · cites it directly · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
  6. Descendant · 3 generations on · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
  7. Descendant · 3 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
  8. Descendant · 2 generations on · 5 of its ownK081936 Solex Catheter, Model SL2593Alsius Corp. · 2008

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22007: 22008: 22010: 12014: 12015: 12016: 22021: 12022: 12023: 1
2003high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 16 · See all
  • K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · cites it directly15descendants
  • K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005 · 2 generations on8descendants
  • K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · 3 generations on7descendants
  • K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 3 generations on6descendants
  • K081936Solex Catheter, Model SL2593Alsius Corp. · 2008 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K811742Hemotherm Model 400Cincinnati Sub-Zero19812
−1K012512Setpoint Endovascular Temperature Management SystemRadiant Medical2002—
0 (this device)K022366Celsius Control SystemInnercool Therapies2003—
+1K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.20034
+2K052443Icy Catheter, Model IC-3893AAlsius Corp.2005—
+3K070161Quattro Catheter Model IC4593Alsius Corp.2007—
+3K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro…Zoll Circulation2010—
+2K081936Solex Catheter, Model SL2593Alsius Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198920
199010
199120
199310
200030
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200720
200820
201010
201410
201510
201620
202110
202210
202310
FIG. 1 — Lineage of K022366, 1981–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213031 Solex 7 Intravascular Heat Exchange Catheter…score 11.0 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K002577Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy…
Summary page 1
…Predicate Devices The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by Medivance, Inc. (K002577), MTKE Advanced Technology, Ltd. (K003349), Seabrook Medical Systems (K902756), Cincinnati Sub-Zero Produ…
Medivance, Inc.20001
*K003349Allon 2001 Modified
Summary page 1
…is substantially equivalent, in whole or in part, to predicate devices manufactured by Medivance, Inc. (K002577), MTKE Advanced Technology, Ltd. (K003349), Seabrook Medical Systems (K902756), Cincinnati Sub-Zero Products, Inc. (M811743), Gaymar Industries, Inc. (K912051)…
Mtre Advanced Technology, Ltd.2000—
*K902756Tropi-Cool
Summary page 1
…e or in part, to predicate devices manufactured by Medivance, Inc. (K002577), MTKE Advanced Technology, Ltd. (K003349), Seabrook Medical Systems (K902756), Cincinnati Sub-Zero Products, Inc. (M811743), Gaymar Industries, Inc. (K912051), and Radiant Medical (K…
Seabrook Medical Systems, Inc.1990—
*K811743Maxitherm
Summary page 1
…by Medivance, Inc. (K002577), MTKE Advanced Technology, Ltd. (K003349), Seabrook Medical Systems (K902756), Cincinnati Sub-Zero Products, Inc. (M811743), Gaymar Industries, Inc. (K912051), and Radiant Medical (KO125 12). Device Descrintion…
Cincinnati Sub-Zero1981—
*K912051Medi-Therm (Mta-5900) & Detachable Hoses
Summary page 1
…E Advanced Technology, Ltd. (K003349), Seabrook Medical Systems (K902756), Cincinnati Sub-Zero Products, Inc. (M811743), Gaymar Industries, Inc. (K912051), and Radiant Medical (KO125 12). Device Descrintion The subject device is a thermal reg…
Gaymar Industries, Inc.19912
*K012512Setpoint Endovascular Temperature Management SystemRadiant Medical2002—

Also cleared against K002577: 2 other devices →

What descends from it? (16)

See all 16

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.200315
K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070

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?

  • The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 20.8 years on median.
  • 6 of the 13 ancestors have a recall of any class.
  • Of its descendants, K030421 (Alsius Corp., 2003) has gone furthest, with 15 descendants of its own.
  • 2 other devices also cite its predicate K002577.

How does its category compare?

All NCX devices

NCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCX

1in 2023

2007: 62008: 32010: 12014: 12015: 12016: 32021: 12022: 12023: 1
2007high 6 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NCX

204in 2016

2007: 28 days median2008: 129 days median2016: 204 days median
2007high 204 (2016) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NCX

28in 2021

2007: 22014: 12021: 28
2007high 28 (2021) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NCX

273in 2025

2007: 42008: 82009: 42010: 92011: 72012: 142013: 312014: 412015: 322016: 3112017: 4502018: 5092019: 4362020: 4152021: 4612022: 5112023: 3732024: 3432025: 273
2007high 511 (2022) · low 4 (2007)2025

MAUDE reports naming product code NCX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200762824
2008312908
20090—04
20101—09
20110—07
20120—014
20130—031
20141—141
20151—032
201632040311
20170—0450
20180—0509
20190—0436
20200—0415
20211—28461
20221—0511
20231—0373
20240—0343
20250—0273
20260—0—

What is it indicated for?

The Celsius ControlTMSystem is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Indications for use as stated in the FDA summary.

Also cleared against K002577

2 other devices cite the same predicate.

  • K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal…Medivance, Inc. · 20146 recalls
  • K033021Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer PadsKimberly-Clark Corp. · 20032 recalls

Recent decisions in NCX

The NCX category page

  • K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc. · 2023
  • K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc. · 2022
  • K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc. · 2021
  • K152946TempedySeiratherm GmbH · 2016
  • K153162HypocoreNovocor Medical Systems, Inc. · 2016

https://510kreport.com/device/K022366 · printed Nov 3, 2026

Cite this page

510(k) Report. “K022366: Celsius Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022366

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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