ClearanceBrief
Panels › Cardiovascular › Product code DWJ · Class 2

System, Thermal Regulating

Regulation 870.5900

5510(k)s in 12 months (161 all time)
3recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DWJ

DateFirm and productCodeLinked 510(k)
Aug 14, 2026Gentherm Medical, LLC
Blanketrol III, Model 233; Thermal regulating system.
Open, Classified
DWJK101589
Aug 14, 2026Gentherm Medical, LLC
Innercool Coolblue Console, Model STx; Thermal regulating system.
Open, Classified
DWJK101589
Aug 14, 2026Gentherm Medical, LLC
Blanketrol II Model 222S; Thermal regulating system.
Open, Classified
DWJK110104
Jun 12, 2025Belmont Instrument LLC
Allon 2001. Part Number: 200-00263
Open, Classified
DWJK024128
Feb 20, 2025Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Open, Classified
DWJK230866
Feb 20, 2025Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Open, Classified
DWJNone listed
Feb 20, 2025Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Open, Classified
DWJK230866
Feb 14, 2025Augustine Temperature Management, LLC
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Open, Classified
DWJK210727
K230866
Feb 14, 2025Augustine Temperature Management, LLC
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Open, Classified
DWJK210727
K230866
Jan 10, 2025Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattr
Completed
DWJNone listed
Jan 10, 2025Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Ma
Completed
DWJNone listed
Jan 10, 2025Augustine Temperature Management, LLC
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Completed
DWJNone listed
Jan 10, 2025Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjuncti
Completed
DWJNone listed
Jan 10, 2025Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets a
Completed
DWJK201779
K220941
Dec 18, 2024Augustine Temperature Management, LLC
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Open, Classified
DWJK201779
K220941
Dec 18, 2024Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction
Open, Classified
DWJK201779
K220941
Dec 18, 2024Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets a
Open, Classified
DWJK201779
K220941
Jul 31, 2024Medivance Inc.
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun St
Open, Classified
DWJK161602
K200225
Mar 26, 2024Medivance Inc.
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Open, Classified
DWJK142702
Oct 31, 2022Belmont Instrument Corporation
CritiCool, thermoregulation device
Open, Classified
DWJK083662
Jan 7, 2020Care Essentials Pty., Ltd.
Cocoon Convective Warming System, Product Code: CWS5000 (110V).
Terminated
DWJK140635
Jan 7, 2020Care Essentials Pty., Ltd.
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
Terminated
DWJK140635
Jul 2, 2019Cincinnati Sub-Zero Products LLC, a Gentherm Company
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Terminated
DWJK101589
Jul 2, 2019Cincinnati Sub-Zero Products LLC, a Gentherm Company
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Terminated
DWJK110104
Jul 2, 2019Cincinnati Sub-Zero Products LLC, a Gentherm Company
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pa
Terminated
DWJK101589
Jun 20, 2019Cincinnati Sub-Zero Products LLC, a Gentherm Company
Norm-O-Temp model 111W
Terminated
DWJNone listed
Jun 20, 2019Cincinnati Sub-Zero Products LLC, a Gentherm Company
Norm-O-Temp model 111Z
Terminated
DWJK120081
Sep 6, 2018Stryker Medical Division of Stryker Corporation
Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer de
Terminated
DWJK152266
K180834
Aug 14, 2018Tec Com Gmbh
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold
Terminated
DWJK140078
Jun 13, 2018Bard Medical Division
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a ra
Terminated
DWJK161602
Apr 20, 2018Pintler Medical LLC
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in a
Completed
DWJK113705
Feb 8, 2018Medtronic Perfusion Systems
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary byp
Terminated
DWJK894980
Jan 23, 20183M Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temp
Terminated
DWJK060865
Jan 23, 20183M Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, th
Terminated
DWJK060865
Nov 8, 2017Bard Medical Division
Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit,
Terminated
DWJK142702
Oct 16, 2017C.R. Bard, Inc.
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad.
Terminated
DWJK142702
Aug 16, 2017C.R. Bard, Inc.
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Terminated
DWJK101092
Jul 21, 2017Stryker Medical Division of Stryker Corporation
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Terminated
DWJK101705
Jun 2, 2017C.R. Bard, Inc.
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Open, Classified
DWJK142702
Mar 29, 2017Stryker Medical Division of Stryker Corporation
Medi-Therm Hyper/Hypothermia System, MTA7900
Terminated
DWJK912051
Aug 5, 2016C.R. Bard, Inc.
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Terminated
DWJK142702
May 6, 2016C.R. Bard, Inc.
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Terminated
DWJK101092
Mar 4, 2016C.R. Bard, Inc.
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temp
Terminated
DWJK142702
Feb 5, 2016C.R. Bard, Inc.
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Terminated
DWJK071341
K101092
Jun 10, 2014Cincinnati Sub-Zero Products Inc
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part numbe
Terminated
DWJK110104
May 22, 2014Smiths Medical ASD, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hyp
Terminated
DWJK040632
Feb 5, 2014Stryker Medical Division of Stryker Corporation
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body
Terminated
DWJK912051
Dec 4, 2013Cincinnati Sub-Zero Products Inc
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, w
Terminated
DWJNone listed
Sep 16, 2013Cincinnati Sub-Zero Products Inc
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maint
Terminated
DWJK101589
Nov 29, 2012Kimberly-Clark Corporation
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Terminated
DWJK033021

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