Product Code: DWJ FDA class 2 21 CFR 870.5900

System, Thermal Regulating

Cardiovascular

The Thermal Regulating System is a cardiovascular device used to control patient body temperature by circulating temperature-controlled water through a blanket or pad in contact with the patient, applied in surgical, intensive care, or cardiac procedure settings. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWJ and it is regulated under 21 CFR 870.5900 within the Cardiovascular medical specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission (82 FR 26807). This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

158

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DWJ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DWJ
Device Class: FDA class 2
Regulation Number: 870.5900
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 158 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260903	Hot Pink Pad Warming System	Apr 16, 2026	Substantially Equivalent	Xodus Medical, Inc.
K252861	Warming System	Apr 07, 2026	Substantially Equivalent	Hangzhou Tappa Medical Technology Co., Ltd.
K251974	Arctic Sun Temperature Management System (Model 5000)	Oct 24, 2025	Substantially Equivalent	Medivance, Inc.
K242964	Celsi Warmer	Jun 20, 2025	Substantially Equivalent	Hadleigh Health Technologies
K243942	Arctic Sun Stat Temperature Management System	Apr 30, 2025	Substantially Equivalent	Medivance, Inc.
K232627	HotDog Warming Mattress + Return Electrode	Apr 18, 2024	Substantially Equivalent	Augustine Temperature Management, LLC
K232502	Cocoon Convective Warming System, Model CWS7000	Feb 21, 2024	Substantially Equivalent	Care Essentials Pty, Ltd.
K231211	Medline ComfortTemp Patient Warming System	Dec 01, 2023	Substantially Equivalent	Medline Industries, LP
K232638	FilteredFlo Warming Blankets	Oct 24, 2023	Substantially Equivalent	Iob Medical, Inc.
K232844	The IQoolTM System	Oct 04, 2023	Substantially Equivalent	Braincool AB
K232508	Barrier EasyWarm Active Self-Warming Blanket	Sep 15, 2023	Substantially Equivalent	Molnlycke Health Care Us, LLC
K231596	IOB Temperature Management System	Jun 30, 2023	Substantially Equivalent	Iob Medical, Inc.
K230866	HotDog Warming Mattress + Return Electrode	Jun 29, 2023	Substantially Equivalent	Augustine Temperature Management, LLC
K221669	IOB Warming Blankets	Dec 27, 2022	Substantially Equivalent	Iob Medical, Inc.
K220941	HotDog Temperature Management System	Sep 23, 2022	Substantially Equivalent	Augustine Temperature Management
K210605	3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation	Apr 29, 2021	Substantially Equivalent	3M Company
K210603	3M Bair Hugger Temperature Management System (Model 675)	Mar 30, 2021	Substantially Equivalent	3M Company
K203085	NOVA Patient Warming System	Nov 12, 2020	Substantially Equivalent	Encompass Group, LLC
K201779	HotDog Temperature Management Controller	Sep 11, 2020	Substantially Equivalent	Augustine Temperature Management
K202197	Astopad Patient Warming System	Sep 04, 2020	Substantially Equivalent	Stihler Electronic GmbH
K200446	STERIS Patient Warming System	Jun 13, 2020	Substantially Equivalent	STERIS Corporation
K200225	Arctic Sun Stat Temperature Management System	Feb 28, 2020	Substantially Equivalent	Medivance, Inc.
K190221	IOB Warming Blankets	Oct 25, 2019	Substantially Equivalent	Iob Medical, Inc.
K181671	Cocoon Convective Warming System	May 02, 2019	Substantially Equivalent	Care Essentials Pty, Ltd.
K180834	Altrix Precision Temperature Management System	Aug 10, 2018	Substantially Equivalent	Stryker Medical
K181699	Level 1 Convective Warmer	Jul 26, 2018	Substantially Equivalent	Smiths Medical Asd, Inc.
K180375	The IQoolTM Warm System	May 18, 2018	Substantially Equivalent	Braincool AB
K171373	3M Bair Hugger Model 675 Total Temperature Management System	Oct 10, 2017	Substantially Equivalent	3M Company
K171149	Altrix Temperature Management Wraps	Jul 18, 2017	Substantially Equivalent	Stryker Medical
K171234	Mistral-Air Warming Unit	May 26, 2017	Substantially Equivalent	The Surgical Company International BV (As the 37company)
K162679	IOB Temperature Management System	Apr 28, 2017	Substantially Equivalent	Iob Medical, Inc.
K162562	OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY	Mar 17, 2017	Substantially Equivalent	Bcg Medical, LLC
K152266	Altrix Precision Temperature Management System	Dec 02, 2016	Substantially Equivalent	Stryker Medical
K161602	Arctic Sun Temperature Management System	Sep 02, 2016	Substantially Equivalent	Medivance, Inc.
K142702	Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad	Dec 18, 2014	Substantially Equivalent	Medivance, Inc.
K140078	TECOTHERM NEO (T NEO)	Nov 14, 2014	Substantially Equivalent	Inspiration Healthcare, Ltd.
K141686	EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY	Oct 28, 2014	Substantially Equivalent	Smith Medical Asd, Inc.
K140635	COCOON CONVECTIVE WARMING SYSTEM	Jul 25, 2014	Substantially Equivalent	Care Essentials Pty, Ltd.
K132048	BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET	Nov 06, 2013	Substantially Equivalent	Molnlycke Health Care Us, LLC
K132454	VITAHEAT PATIENT WARMING SYSTEM	Oct 04, 2013	Substantially Equivalent	Vitaheat Medical, LLC
K131361	WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET	Jul 29, 2013	Substantially Equivalent	Covidien
K123083	COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT	Apr 17, 2013	Substantially Equivalent	Covidien
K123946	WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS	Jan 17, 2013	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K113705	PINTLER PATIENT WARMING SYSTEM	Aug 31, 2012	Substantially Equivalent	Pintler Medical
K121720	WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM	Aug 20, 2012	Substantially Equivalent	Welkins, LLC
K120849	HYBRID ARCTICGEL PAD	Jul 20, 2012	Substantially Equivalent	Medivance, Inc.
K121669	WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)	Jul 03, 2012	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K120081	NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS	Feb 17, 2012	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K112488	HOTDOG PATIENT WARMING SYSTEM	Nov 23, 2011	Substantially Equivalent	Augustine Biomedical & Design, LLC
K102856	SIROCCO THERMAL REGULATING SYSTEM	Jun 30, 2011	Substantially Equivalent	Galmaz Biotech S.L.
K110104	BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM	Feb 04, 2011	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K100585	MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900	Jan 20, 2011	Substantially Equivalent	Gaymar Industries, Inc.
K102112	CRITICOOL PRO	Nov 18, 2010	Substantially Equivalent	Mtre Advanced Technology , Ltd.
K093244	UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX	Oct 19, 2010	Substantially Equivalent	Geratherm Medical AG
K101148	WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS	Oct 01, 2010	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K101589	BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS	Sep 20, 2010	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K093694	GERATHERM UNIQUERESC	Sep 20, 2010	Substantially Equivalent	Geratherm Medical AG
K101092	ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000	Jul 16, 2010	Substantially Equivalent	Medivance, Inc.
K101705	MISTRAL-AIR WARMING SYSTEM	Jul 02, 2010	Substantially Equivalent	The Surgical Company International B.V.
K094056	HOTDOG MULTI FUNCTION CONTROLLER	Jun 03, 2010	Substantially Equivalent	Augustine Biomedical & Design, LLC
K092807	HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103	Dec 10, 2009	Substantially Equivalent	Augustine Biomedical & Design, LLC
K083336	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	Jun 03, 2009	Substantially Equivalent	Smiths Medical Asd, Inc.
K083662	CRITICOOL	Mar 26, 2009	Substantially Equivalent	Mtre Advanced Technology , Ltd.
K083135	MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002	Oct 31, 2008	Substantially Equivalent	Thermogear, Inc.
K073712	SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100	Jun 06, 2008	Substantially Equivalent	Adroit Medical Systems, Inc.
K080763	TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT	May 30, 2008	Substantially Equivalent	Talley Medical
K072513	DM-EMG	Dec 07, 2007	Substantially Equivalent	Gvp Elettronica Srl
K071918	CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002	Nov 09, 2007	Substantially Equivalent	Thermogear, Inc.
K071341	MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000	Aug 03, 2007	Substantially Equivalent	Medivance, Inc.
K070112	RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM	Jul 13, 2007	Substantially Equivalent	Medcool, Inc.
K061902	COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1	Dec 08, 2006	Substantially Equivalent	Inditherm Medical
K062794	PRN THERMALCARE, MODEL 3000	Dec 07, 2006	Substantially Equivalent	American Healthcare Products, Inc.
K061513	LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET	Aug 01, 2006	Substantially Equivalent	Smiths Medical Asd, Inc.
K051336	GERATHERM SOS-RESCUE BAG	Jun 29, 2006	Substantially Equivalent	R.G. Enterprises, Inc.
K051278	GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)	Jun 29, 2006	Substantially Equivalent	Rg Ent., Inc.
K052392	HOT DOG PATIENT WARMING SYSTEM	May 04, 2006	Substantially Equivalent	Augustine Biomedical & Design, LLC
K051419	INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1	Apr 27, 2006	Substantially Equivalent	Inditherm Medical
K060865	BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850	Apr 24, 2006	Substantially Equivalent	Arizant Healthcare, Inc.
K053645	MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS	Mar 09, 2006	Substantially Equivalent	Arizant Healthcare, Inc.
K051097	GERATHERM SOS-RESCUE BLANKET	Feb 24, 2006	Substantially Equivalent	Rg Ent., Inc.
K031728	KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET	Oct 12, 2004	Substantially Equivalent	Klimamed Technologie Medizingerate GmbH
K041686	BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM	Jun 30, 2004	Substantially Equivalent	Arizant Healthcare, Inc.
K040911	VITALHEAT	Jun 22, 2004	Substantially Equivalent	Dynatherm Medical, Inc.
K040632	SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000	Apr 27, 2004	Substantially Equivalent	Smiths Medical Asd, Inc.
K040440	HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)	Apr 27, 2004	Substantially Equivalent	Http Hypothermia Therapy
K033021	KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS	Nov 12, 2003	Substantially Equivalent	Kimberly-Clark Corp.
K024128	ALLON 2001 VERSION 5	Feb 10, 2003	Substantially Equivalent	Mtre Advanced Technology , Ltd.
K023934	RAPID THERMAL EXCHANGE SYSTEM	Jan 23, 2003	Substantially Equivalent	Avacore Technologies, Inc.
K022903	CHILLBUSTER	Nov 27, 2002	Substantially Equivalent	Microtek Medical, Inc.
K014210	PALMO THERMOREGULATION INTERFACE ACCESSORY	Aug 16, 2002	Substantially Equivalent	Avacore Technologies, Inc.
K021473	BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM	Jul 09, 2002	Substantially Equivalent	Augustine Medical, Inc.
K011859	KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS	May 01, 2002	Substantially Equivalent	Klimamed Technologie Medizingerate GmbH
K020604	WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300	Apr 23, 2002	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K014121	WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860	Jan 11, 2002	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K011907	SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM	Dec 18, 2001	Substantially Equivalent	Sims Level 1, Inc.
K010338	ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200	Mar 07, 2001	Substantially Equivalent	Medivance, Inc.
K003368	ACROTHERM	Jan 19, 2001	Substantially Equivalent	Aquarius Medical Corp.
K003349	ALLON 2001 MODIFIED	Nov 13, 2000	Substantially Equivalent	Mtre Advanced Technology , Ltd.
K002577	ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS	Oct 26, 2000	Substantially Equivalent	Medivance, Inc.
K001149	AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK	Sep 06, 2000	Substantially Equivalent	Augustine Medical, Inc.
K001546	ALLON 2001	Jun 08, 2000	Substantially Equivalent	Mtre Advanced Technology , Ltd.
K981093	WESCO BLANKET	Mar 28, 2000	Substantially Equivalent	Wesco, Inc.
K992386	ALLON 2000	Mar 07, 2000	Substantially Equivalent	Mtre Advanced Technology , Ltd.
K991684	CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001	Mar 01, 2000	Substantially Equivalent	Thermogear, Inc.
K973705	CONTOR TABLE SURFACE	Aug 07, 1998	Substantially Equivalent	Hill-Rom, Inc.
K970367	THERMO-STAT SYSTEM	Dec 17, 1997	Substantially Equivalent	Aquarius Medical Corp.
K964673	BAIR HUGGER MODEL 630 CARDIAC BLANKET	Jun 26, 1997	Substantially Equivalent	Augustine Medical, Inc.
K964377	THERMAL REGULATION SYSTEM BLANKET	Apr 23, 1997	Substantially Equivalent	Gibeck, Inc.
K963731	TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT	Apr 22, 1997	Substantially Equivalent	Enthermics Medical Systems, Inc.
K960511	GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET	Jan 13, 1997	Substantially Equivalent	Gibeck, Inc.
K960167	SYSTEM, THERMAL REGULATING 74-DWJ	Jun 17, 1996	Substantially Equivalent	Augustine Medical, Inc.
K952329	LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM	Jan 17, 1996	Substantially Equivalent	Progressive Dynamics, Inc.
K952864	BAIR HUGGER MODEL 655 BLANKET	Sep 12, 1995	Substantially Equivalent	Augustine Medical, Inc.
K952086	TROPICAIR CONVECTIVE WARMING BLANKETS	Sep 06, 1995	Substantially Equivalent	Seabrook Medical Systems, Inc.
K946196	TROPICAIR CONVECTIVE WARING SYSTEM	Sep 06, 1995	Substantially Equivalent	Seabrook Medical Systems, Inc.
K950416	BAIR HUGGER MODEL 600 UNIT, BLANKETS	Aug 29, 1995	Substantially Equivalent	Augustine Medical, Inc.
K942881	TC 3000	May 23, 1995	Substantially Equivalent	Gaymar Industries, Inc.
K942790	WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)	Jan 24, 1995	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K942599	WARM AIR WARMING UNIT	Jan 24, 1995	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K943276	WARMTOUCH PLASTIC WARMING COVER	Sep 19, 1994	Substantially Equivalent	Mallinckrodt Medical
K940171	CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM	Mar 09, 1994	Substantially Equivalent	Cabot Medical Corp.
K933764	LIFE-AIR 1000 PATIENT WARMING COVER	Nov 09, 1993	Substantially Equivalent	Progressive Dynamics, Inc.
K930345	TC2000 POWER UNIT AND ACCESSORIES	Aug 06, 1993	Substantially Equivalent	Gaymar Industries, Inc.
K923104	TROPIC-AIR	Jul 13, 1993	Substantially Equivalent	Seabrook Medical Systems, Inc.
K921920	SOFT-TEMP	Dec 11, 1992	Substantially Equivalent	Adroit Medical Systems, Inc.
K921165	BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540	Aug 06, 1992	Substantially Equivalent	Augustine Medical, Inc.
K920432	BAIR HUGGER CUB BLANKET- SHORT MODEL 536	Jun 18, 1992	Substantially Equivalent	Augustine Medical, Inc.
K914382	LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM	Apr 21, 1992	Substantially Equivalent	Progressive Dynamics, Inc.
K914383	LIFE-AIR 1000 PATIENT WARMING COVERS	Mar 30, 1992	Substantially Equivalent	Progressive Dynamics, Inc.
K920265	BAIR HUGGER PATIENT WARMING SYSTEM	Mar 27, 1992	Substantially Equivalent	Augustine Medical, Inc.
K914805	TC-1000, TC-1050 SYSTEM	Jan 07, 1992	Substantially Equivalent	Gaymar Industries, Inc.
K913734	BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER	Oct 23, 1991	Substantially Equivalent	Augustine Medical, Inc.
K913016	WARMTOUCH	Sep 04, 1991	Substantially Equivalent	Advanced Warming Systems, Inc.
K912051	MEDI-THERM (MTA-5900) & DETACHABLE HOSES	Jul 30, 1991	Substantially Equivalent	Gaymar Industries, Inc.
K910327	WARMAIR SYSTEM	May 16, 1991	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K904690	TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM	Feb 01, 1991	Substantially Equivalent	Marquest Medical Products, Inc.
K902650	BODYHEAT	Dec 20, 1990	Substantially Equivalent	Medadvances, Inc.
K902756	TROPI-COOL	Oct 22, 1990	Substantially Equivalent	Seabrook Medical Systems, Inc.
K903360	BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION	Aug 14, 1990	Substantially Equivalent	Augustine Medical, Inc.
K900186	BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET	Apr 10, 1990	Substantially Equivalent	Shiley, Inc.
K894980	BIO-CAL 370 HEATER/COOLER	Nov 02, 1989	Substantially Equivalent	Bio Medicus, Inc.
K890575	ACCUTHERM PTS-200	May 05, 1989	Substantially Equivalent	Medical Repackers Co.
K882442	RK2000 K-THERMIA SYSTEM	Sep 06, 1988	Substantially Equivalent	Baxter Healthcare Corp
K882035	HEART-CHILL SALINE SLUSH PAD	Jul 28, 1988	Substantially Equivalent	Buckman Co., Inc.
K881322	MINI-TEMP(TM)	Jun 22, 1988	Substantially Equivalent	Seabrook Medical Systems, Inc.
K873546	VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM	Jan 29, 1988	Substantially Equivalent	Reimers Engineering, Inc.
K873745	BAIR HUGGER(TM) - PATIENT WARMING SYSTEM	Nov 06, 1987	Substantially Equivalent	Augustine Medical, Inc.
K854856	THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT	Jun 02, 1986	Substantially Equivalent	Thermorite, Inc.
K820814	THERMO-K	Apr 29, 1982	Substantially Equivalent	American Medical Systems, Inc.
K812955	EAST WATER UNIT MARK 3	Dec 29, 1981	Substantially Equivalent	Cairco , Ltd.
K811742	HEMOTHERM MODEL 400	Aug 13, 1981	Substantially Equivalent	Cincinnati Sub-Zero
K811743	MAXITHERM	Jul 16, 1981	Substantially Equivalent	Cincinnati Sub-Zero
K801253	CREST ELECTRONIC WARMING BLANKET	Jan 02, 1981	Substantially Equivalent	Penlon, Inc.
K800812	MEDI-THERM	Apr 24, 1980	Substantially Equivalent	Gaymar Industries, Inc.
K772015	PATIENT HEATER SYSTEM, MODEL PH112	Nov 15, 1977	Substantially Equivalent	Carolina Medical Electronics
K771537	AQUAMATIC K-MODULE MODEL K-20	Sep 06, 1977	Substantially Equivalent	Gorman Rupp Industries
K770839	AQUAMATIC K-77	Jun 08, 1977	Substantially Equivalent	Gorman Rupp Industries
K761087	ELECTRONIC CONTROL UNIT	Dec 06, 1976	Substantially Equivalent	Gorman Rupp Industries