NCX · Class II · 21 CFR 870.5900

FDA Product Code NCX: System, Hypothermia, Intravenous, Cooling

Leading manufacturers include Alsius Corp., Zoll Circulation, Inc. and Radiant Medical.

26
Total
26
Cleared
145d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Hypothermia, Intravenous, Cooling Devices (Product Code NCX)

26 devices
1–24 of 26
Cleared Jan 13, 2023
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.
Neurology · 30d
Cleared Jun 02, 2022
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.
Neurology · 149d
Cleared Dec 20, 2021
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.
Neurology · 90d
Cleared Sep 15, 2016
TEMPEDY
K152946
Seiratherm GmbH
Neurology · 345d
Cleared May 24, 2016
Hypocore
K153162
Novocor Medical Systems, Inc.
Neurology · 204d
Cleared Mar 24, 2016
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
K153226
Zoll Circulation, Inc.
Neurology · 139d
Cleared Oct 30, 2015
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
K150046
Zoll Circulation, Inc.
Neurology · 291d
Cleared Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139
Zoll Circulation
Neurology · 154d
Cleared Oct 12, 2010
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
K101987
Zoll Circulation
Neurology · 90d
Cleared Oct 17, 2008
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
K080908
Innercool Therapies, Inc.- A Delaware Corporation
Neurology · 199d
Cleared Aug 13, 2008
SOLEX CATHETER, MODEL SL2593
K081936
Alsius Corp.
Neurology · 37d
Cleared Aug 07, 2008
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
K080899
Medivance, Inc.
Neurology · 129d
Cleared Aug 23, 2007
THERMOGARD XP THERMAL REGULATION SYSTEM
K072234
Alsius Corp.
Neurology · 13d
Cleared Jun 01, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071358
Radiant Medical
Neurology · 17d
Cleared May 09, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071008
Radiant Medical
Neurology · 30d
Cleared Feb 15, 2007
QUATTRO CATHETER MODEL IC4593
K070161
Alsius Corp.
Neurology · 29d
Cleared Jan 22, 2007
THERMOGARD THERMAL REGULATION SYSTEM
K063829
Alsius Corp.
Neurology · 27d
Cleared Jan 08, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K063405
Radiant Medical
Neurology · 60d
Cleared Apr 26, 2006
COOLGARD 3000
K060308
Alsius Corp.
Neurology · 78d
Cleared Oct 17, 2005
ICY CATHETER, MODEL IC-3893A
K052443
Alsius Corp.
Neurology · 41d
Cleared Oct 11, 2005
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A
K051912
Alsius Corp.
Neurology · 89d
Cleared Aug 01, 2003
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
K014241
Alsius Corp.
Neurology · 583d
Cleared Jun 11, 2002
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
K012512
Radiant Medical
Neurology · 309d

About Product Code NCX - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code NCX since 2002, with 26 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.