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)
Top companies in DWJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Gentherm Medical, LLC Blanketrol III, Model 233; Thermal regulating system. Open, Classified |
DWJ | K101589 |
| Aug 14, 2026 | Gentherm Medical, LLC Innercool Coolblue Console, Model STx; Thermal regulating system. Open, Classified |
DWJ | K101589 |
| Aug 14, 2026 | Gentherm Medical, LLC Blanketrol II Model 222S; Thermal regulating system. Open, Classified |
DWJ | K110104 |
| Jun 12, 2025 | Belmont Instrument LLC Allon 2001. Part Number: 200-00263 Open, Classified |
DWJ | K024128 |
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia Open, Classified |
DWJ | K230866 |
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia Open, Classified |
DWJ | None listed |
| Feb 20, 2025 | Augustine Temperature Management, LLC Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia Open, Classified |
DWJ | K230866 |
| Feb 14, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | K210727 K230866 |
| Feb 14, 2025 | Augustine Temperature Management, LLC Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136
used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | K210727 K230866 |
| Jan 10, 2025 | Augustine 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 |
DWJ | None listed |
| Jan 10, 2025 | Augustine 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 |
DWJ | None listed |
| Jan 10, 2025 | Augustine Temperature Management, LLC Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses. Completed |
DWJ | None listed |
| Jan 10, 2025 | Augustine 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 |
DWJ | None listed |
| Jan 10, 2025 | Augustine 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 |
DWJ | K201779 K220941 |
| Dec 18, 2024 | Augustine Temperature Management, LLC Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses. Open, Classified |
DWJ | K201779 K220941 |
| Dec 18, 2024 | Augustine 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 |
DWJ | K201779 K220941 |
| Dec 18, 2024 | Augustine 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 |
DWJ | K201779 K220941 |
| Jul 31, 2024 | Medivance 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 |
DWJ | K161602 K200225 |
| Mar 26, 2024 | Medivance Inc. Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C Open, Classified |
DWJ | K142702 |
| Oct 31, 2022 | Belmont Instrument Corporation CritiCool, thermoregulation device Open, Classified |
DWJ | K083662 |
| Jan 7, 2020 | Care Essentials Pty., Ltd. Cocoon Convective Warming System, Product Code: CWS5000 (110V). Terminated |
DWJ | K140635 |
| Jan 7, 2020 | Care Essentials Pty., Ltd. Cocoon Convective Warming System, Product Code: CWS4000 (110V). Terminated |
DWJ | K140635 |
| Jul 2, 2019 | Cincinnati 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 |
DWJ | K101589 |
| Jul 2, 2019 | Cincinnati 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 |
DWJ | K110104 |
| Jul 2, 2019 | Cincinnati 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 |
DWJ | K101589 |
| Jun 20, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Norm-O-Temp
model 111W Terminated |
DWJ | None listed |
| Jun 20, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Norm-O-Temp
model 111Z Terminated |
DWJ | K120081 |
| Sep 6, 2018 | Stryker 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 |
DWJ | K152266 K180834 |
| Aug 14, 2018 | Tec 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 |
DWJ | K140078 |
| Jun 13, 2018 | Bard 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 |
DWJ | K161602 |
| Apr 20, 2018 | Pintler 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 |
DWJ | K113705 |
| Feb 8, 2018 | Medtronic 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 |
DWJ | K894980 |
| Jan 23, 2018 | 3M 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 |
DWJ | K060865 |
| Jan 23, 2018 | 3M 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 |
DWJ | K060865 |
| Nov 8, 2017 | Bard 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 |
DWJ | K142702 |
| Oct 16, 2017 | C.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 |
DWJ | K142702 |
| Aug 16, 2017 | C.R. Bard, Inc. Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US Terminated |
DWJ | K101092 |
| Jul 21, 2017 | Stryker Medical Division of Stryker Corporation MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM Terminated |
DWJ | K101705 |
| Jun 2, 2017 | C.R. Bard, Inc. Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 Open, Classified |
DWJ | K142702 |
| Mar 29, 2017 | Stryker Medical Division of Stryker Corporation Medi-Therm Hyper/Hypothermia System, MTA7900 Terminated |
DWJ | K912051 |
| Aug 5, 2016 | C.R. Bard, Inc. Medivance ArcticGel Neonatal Pad
The pad is designed to fit into an incubator and provide whole body cooling for patients. Terminated |
DWJ | K142702 |
| May 6, 2016 | C.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 |
DWJ | K101092 |
| Mar 4, 2016 | C.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 |
DWJ | K142702 |
| Feb 5, 2016 | C.R. Bard, Inc. Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. Terminated |
DWJ | K071341 K101092 |
| Jun 10, 2014 | Cincinnati 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 |
DWJ | K110104 |
| May 22, 2014 | Smiths 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 |
DWJ | K040632 |
| Feb 5, 2014 | Stryker 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 |
DWJ | K912051 |
| Dec 4, 2013 | Cincinnati 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 |
DWJ | None listed |
| Sep 16, 2013 | Cincinnati 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 |
DWJ | K101589 |
| Nov 29, 2012 | Kimberly-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 |
DWJ | K033021 |
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