Atlas FDA

NCX

26 FDA 510(k) clearances · Product code

129 daysmedian time to decision
309 days90th percentile
26clearances measured

FDA profile

Official device name
System, Hypothermia, Intravenous, Cooling
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5900
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 461 · 2022: 511 · 2023: 373 · 2024: 343 · 2025: 276 · 2026: 149
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console (K223746)Zoll Circulation, Inc.2023-01-13
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console (K220008)Zoll Circulation, Inc.2022-06-02
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console (K213031)Zoll Circulation, Inc.2021-12-20
TEMPEDY (K152946)Seiratherm GmbH2016-09-15
Hypocore (K153162)Novocor Medical Systems, Inc.2016-05-24
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (K153226)Zoll Circulation, Inc.2016-03-24
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (K150046)Zoll Circulation, Inc.2015-10-30
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (K141139)Zoll Circulation2014-10-03
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 (K101987)Zoll Circulation2010-10-12
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (K080908)Innercool Therapies, Inc.- A Delaware Corporation2008-10-17
SOLEX CATHETER, MODEL SL2593 (K081936)Alsius Corp.2008-08-13
ARCTIC BLAST INTRAVENOUS FLUID CHILLER (K080899)Medivance, Inc.2008-08-07
THERMOGARD XP THERMAL REGULATION SYSTEM (K072234)Alsius Corp.2007-08-23
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K071358)Radiant Medical2007-06-01
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K071008)Radiant Medical2007-05-09
QUATTRO CATHETER MODEL IC4593 (K070161)Alsius Corp.2007-02-15
THERMOGARD THERMAL REGULATION SYSTEM (K063829)Alsius Corp.2007-01-22
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K063405)Radiant Medical2007-01-08
COOLGARD 3000 (K060308)Alsius Corp.2006-04-26
ICY CATHETER, MODEL IC-3893A (K052443)Alsius Corp.2005-10-17
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B (K051912)Alsius Corp.2005-10-11
CELSIUS CONTROL SYSTEM (K033623)Innercool Therapies, Inc.2004-05-21
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (K030421)Alsius Corp.2003-10-23
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241)Alsius Corp.2003-08-01
CELSIUS CONTROL SYSTEM (K022366)Innercool Therapies2003-01-27
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM (K012512)Radiant Medical2002-06-11

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Every clearance here is in the API, with alerts when new ones post.