Product Code: FMT FDA class 2 21 CFR 880.5130

Warmer, Infant Radiant

General Hospital

The Infant Radiant Warmer is a device used in neonatal care that provides infrared radiant heat to maintain the body temperature of newborns, particularly premature or low-birth-weight infants, during examination and stabilization. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMT, regulated under 21 CFR 880.5130 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FMT
Device Class: FDA class 2
Regulation Number: 880.5130
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 92 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243606	Babyroo TN300	Jan 17, 2025	Substantially Equivalent	Draeger Medical Systems, Inc.
K230278	Babyroo TN300	May 30, 2023	Substantially Equivalent	Draeger Medical Systems, Inc.
K213551	Giraffe Omnibed Carestation CS1	Mar 02, 2022	Substantially Equivalent	Datex Ohmeda, Inc.
K201628	Panda iRes Warmer, Giraffe Warmer	Feb 12, 2021	Substantially Equivalent	GE Healthcare
K200319	HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable	Apr 02, 2020	Substantially Equivalent	Deroyal Industries, Inc.
K191425	Hydro-Temp Neonatal Skin Temperature Probe Cover	Jan 21, 2020	Substantially Equivalent	Deroyal Industries, Inc.
K173516	NuBorne Infant Warmer	Aug 17, 2018	Substantially Equivalent	International Biomedical
K123309	GIRAFFE AND PANDA WARMERS	Feb 05, 2013	Substantially Equivalent	Ohmeda Medical
K120642	RESUSCITAIRE WITH AUTOBREATH	Nov 02, 2012	Substantially Equivalent	Draeger Medical Systems, Inc.
K122267	GIRAFFE AND PANDA WARMERS	Oct 02, 2012	Substantially Equivalent	Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
K121625	LULLABY TM WARMER	Sep 14, 2012	Substantially Equivalent	Wipro GE Healthcare Private, Ltd.
K120937	SUNFLOWER WARNER	Jul 06, 2012	Substantially Equivalent	Atom Medical Corporation
K102227	INFA WARMER I	Jan 21, 2011	Substantially Equivalent	Atom Medical Corporation
K101804	GIRAFFE AND PANDA WARMERS	Jul 21, 2010	Substantially Equivalent	Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
K090697	MODIFICATION TO: GIRAFFE AND PANDA WARMER	Apr 16, 2009	Substantially Equivalent	Ohmeda Medical
K072157	MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)	Aug 27, 2007	Substantially Equivalent	Ohmeda Medical
K070377	GIRAFFE AND PANDA WARMER	Jul 11, 2007	Substantially Equivalent	Ohmeda Medical
K060461	V-505 INFA WARMER	Apr 28, 2006	Substantially Equivalent	Atom Medical, Inc.
K033040	PHOENIX INFANT RADIANT WARMER, MODEL 100NWS	Dec 17, 2003	Substantially Equivalent	International Hospital Supply Co.
K020966	RPI REPLACEMENT HEATING ELEMENTS	Jun 13, 2002	Substantially Equivalent	Replacement Parts Industries, Inc.
K020219	RPI SKIN OR AIR TEMPERATURE PROBE	Apr 12, 2002	Substantially Equivalent	Replacement Parts Industries, Inc.
K012229	SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC	Sep 10, 2001	Substantially Equivalent	National Custom Ent., Inc.
K003335	RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER	Nov 17, 2000	Substantially Equivalent	Hill-Rom Air-Shields
K002355	ATOM INFA WARMER V-505	Oct 10, 2000	Substantially Equivalent	Atom Medical Corp
K971366	INCUWARMER	Jan 05, 1998	Substantially Equivalent	Hill-Rom, Inc.
K972885	SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970	Oct 30, 1997	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K971198	BABYTHERM 8004 BABYTHERM 8010	Oct 03, 1997	Substantially Equivalent	Drager, Inc.
K970686	ACCUTEMP-PROBE	Aug 25, 1997	Substantially Equivalent	Kentec Medical, Inc.
K971695	SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER	Jul 28, 1997	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K971461	SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)	Jul 16, 1997	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K970432	INFANT RADIANT WARMER - MODELS IW910 AND IW920	May 07, 1997	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K970074	STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)	Apr 03, 1997	Substantially Equivalent	Hill-Rom, Inc.
K964401	KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)	Feb 06, 1997	Substantially Equivalent	Ludlow Technical Products
K950422	FIRST TOUCH DISPOSABLES TEMPERATURE PROBES	Jan 23, 1997	Substantially Equivalent	First Touch Disposables, Inc.
K963058	INFANT WARMER SYSTEM	Oct 01, 1996	Substantially Equivalent	Ohmeda Medical
K960080	ACCUTEMP PROBE	May 01, 1996	Substantially Equivalent	Kentec Medical, Inc.
K952807	TEMPERATURE PROBE-TP650	Apr 04, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K952805	TEMPERATURE PROBE-TP550	Apr 04, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K952804	TEMPERATURE PROBE-TP450	Apr 04, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K952803	TEMPERATURE PROBE-TP350	Apr 04, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K952801	TEMPERATURE PROBE-TP250	Apr 04, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K952800	TEMPERATURE PROBE-TP150	Apr 04, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K953489	DRAGER INFANT RADIANT WARMERN RH600	Feb 09, 1996	Substantially Equivalent	Drager, Inc.
K950143	ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE	Sep 25, 1995	Substantially Equivalent	Astral, Ltd.
K946005	ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE	Sep 25, 1995	Substantially Equivalent	Astral, Ltd.
K940951	RW RESUCITAIRE INFANT RADIANT WARMER	May 03, 1995	Substantially Equivalent	Air-Shields, Inc.
K942905	DISPOSABLE TEMPERATURE PROBE COVER	Feb 27, 1995	Substantially Equivalent	Arbo Medical, Inc.
K942904	STABILET	Sep 16, 1994	Substantially Equivalent	Hill-Rom, Inc.
K934677	U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE	Jul 05, 1994	Substantially Equivalent	U.S. Medical Corp.
K935609	4002 INFANT SCALE FOR INCUBATORS AND WARMERS	Jul 01, 1994	Substantially Equivalent	Scale-Tronix, Inc.
K931529	INFANT WARMER	Mar 11, 1994	Substantially Equivalent	Medix I.C.S.A.
K926030	KLEAR-TEMP	Feb 24, 1994	Substantially Equivalent	Cas Medical Systems, Inc.
K925006	HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO	Jan 31, 1994	Substantially Equivalent	Deroyal Industries, Inc.
K921547	ADVANTAGE	Jul 23, 1993	Substantially Equivalent	Kci
K921766	OHIO INFANT WARMER SYSTEM	Apr 23, 1993	Substantially Equivalent	Ohmeda Medical
K912921	VSI 1000	Oct 30, 1992	Substantially Equivalent	Vitaltrends Technology, Inc.
K915831	THERMAL PROBE COVER	Jun 08, 1992	Substantially Equivalent	Vermont Medical, Inc.
K913945	STABILET INFANT RADIANT WARMER MODEL 2000C	Feb 12, 1992	Substantially Equivalent	Hill-Rom, Inc.
K910915	PATIENT WARMER MODEL 100C	Jul 16, 1991	Substantially Equivalent	Developmed Corp.
K885350	PREEMICARE SERIES 2000 INFANT WARMER	Aug 07, 1989	Substantially Equivalent	Preemicare Corp.
K884285	MODEL WC-115 MOBILE BASSINET	Dec 22, 1988	Substantially Equivalent	Gempco, Inc.
K884283	MODEL WC-107 MOBILE NEWBORN BED	Dec 22, 1988	Substantially Equivalent	Gempco, Inc.
K884280	MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET	Dec 22, 1988	Substantially Equivalent	Gempco, Inc.
K881670	ACCUTEMP PLUS	Nov 22, 1988	Substantially Equivalent	Sentry Medical Products, Inc.
K884160	OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM	Nov 21, 1988	Substantially Equivalent	Ohmeda Medical
K881713	SPECIAL PROCEDURES BASE UNIT MODEL 500	Jul 12, 1988	Substantially Equivalent	Gempco, Inc.
K875270	INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS	Jan 19, 1988	Substantially Equivalent	Air-Shields, Inc.
K872742	WARM WEIGH MODELS I-20/W-30 INFANT SCALE	Oct 20, 1987	Substantially Equivalent	Air-Shields, Inc.
K871178	MTC XI UL	Oct 09, 1987	Substantially Equivalent	Aragona Medical, Inc.
K871177	NTH 101 UL	Oct 09, 1987	Substantially Equivalent	Aragona Medical, Inc.
K871594	BIRTHING ROOM WARMER	Jun 05, 1987	Substantially Equivalent	Air-Shields, Inc.
K862921	MODEL 10200 PREMATURE INFANT INCUBATOR	Apr 01, 1987	Substantially Equivalent	Rotem Industries C/O Medsys, Inc.
K865012	YSI MODEL 801	Mar 04, 1987	Substantially Equivalent	Yellow Springs Instrument Co., Inc.
K863208	OHMEDA AUXILIARY POWER SYSTEM	Oct 03, 1986	Substantially Equivalent	Ohmeda Medical
K861781	DELIVERY ROOM WARMER	Jul 15, 1986	Substantially Equivalent	Air-Shields, Inc.
K853926	NEOCARE MODEL 800 INFANT RADIANT WARMER	Feb 26, 1986	Substantially Equivalent	Draeger Medical, Inc.
K852943	NEO SHIELD	Nov 08, 1985	Substantially Equivalent	Gaymar Industries, Inc.
K853351	OHMEDA HEAT REFLECTING PATCH	Oct 17, 1985	Substantially Equivalent	Ohmeda Medical
K853794	NEOGUARD REFLECTOR	Oct 16, 1985	Substantially Equivalent	Cas Medical Systems, Inc.
K851449	OHMEDA 5000 INFANT WARMER SYSTEM	Jun 07, 1985	Substantially Equivalent	Ohmeda Medical
K850069	BORNING NEONATAL RESUSCITATOIN CENTER	May 30, 1985	Substantially Equivalent	Borning Corp.
K840792	INFANT RADIANT WARMER	May 25, 1984	Substantially Equivalent	Hatch Bio Medical
K833802	INFANT WARMER	Apr 05, 1984	Substantially Equivalent	Kinetic Concepts, Inc.
K840858	OHIO 3300 INFANT WARMER SYSTEM	Mar 23, 1984	Substantially Equivalent	Ohio Medical Products
K840857	OHIO 3000 INFANT WARMER SYSTEM	Mar 23, 1984	Substantially Equivalent	Ohio Medical Products
K832637	AMEDA NEONATAL RESUSCITATION UNIT-	Dec 22, 1983	Substantially Equivalent	Egnell, Inc.
K830748	RESUSCITAIRE	Jun 22, 1983	Substantially Equivalent	Vickers America Medical Corp.
K813408	SAGE 2200 STERILE SPECIMEN CONTAINER	Jan 25, 1982	Substantially Equivalent	Sage Products, Inc.
K812745	WARMING LISTHTS #96H & 96HT	Nov 02, 1981	Substantially Equivalent	J. H. Emerson Co.
K802365	OHIO RADIANT WARMER	Oct 23, 1980	Substantially Equivalent	Ohio Medical Products
K790948	TEMP-GUARD TM	Sep 24, 1979	Substantially Equivalent	Gordon Consultants, Inc.
K790137	INFANT CARE SYSTEM	Mar 06, 1979	Substantially Equivalent	Narco Air-Shields