Atlas FDA

FMT

92 FDA 510(k) clearances · Product code

111 daysmedian time to decision
290 days90th percentile
92clearances measured

FDA profile

Official device name
Warmer, Infant Radiant
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5130
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 473 · 2022: 153 · 2023: 175 · 2024: 257 · 2025: 363 · 2026: 203
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Babyroo TN300 (K243606)Draeger Medical Systems, Inc.2025-01-17
Babyroo TN300 (K230278)Draeger Medical Systems, Inc.2023-05-30
Giraffe Omnibed Carestation CS1 (K213551)Datex Ohmeda, Inc.2022-03-02
Panda iRes Warmer, Giraffe Warmer (K201628)GE Healthcare2021-02-12
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable (K200319)Deroyal Industries, Inc.2020-04-02
Hydro-Temp Neonatal Skin Temperature Probe Cover (K191425)Deroyal Industries, Inc.2020-01-21
NuBorne Infant Warmer (K173516)International Biomedical2018-08-17
GIRAFFE AND PANDA WARMERS (K123309)Ohmeda Medical2013-02-05
RESUSCITAIRE WITH AUTOBREATH (K120642)Draeger Medical Systems, Inc.2012-11-02
GIRAFFE AND PANDA WARMERS (K122267)Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2012-10-02
LULLABY TM WARMER (K121625)Wipro GE Healthcare Private, Ltd.2012-09-14
SUNFLOWER WARNER (K120937)Atom Medical Corporation2012-07-06
INFA WARMER I (K102227)Atom Medical Corporation2011-01-21
GIRAFFE AND PANDA WARMERS (K101804)Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2010-07-21
MODIFICATION TO: GIRAFFE AND PANDA WARMER (K090697)Ohmeda Medical2009-04-16
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072157)Ohmeda Medical2007-08-27
GIRAFFE AND PANDA WARMER (K070377)Ohmeda Medical2007-07-11
V-505 INFA WARMER (K060461)Atom Medical, Inc.2006-04-28
PHOENIX INFANT RADIANT WARMER, MODEL 100NWS (K033040)International Hospital Supply Co.2003-12-17
RPI REPLACEMENT HEATING ELEMENTS (K020966)Replacement Parts Industries, Inc.2002-06-13
RPI SKIN OR AIR TEMPERATURE PROBE (K020219)Replacement Parts Industries, Inc.2002-04-12
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC (K012229)National Custom Ent., Inc.2001-09-10
RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER (K003335)Hill-Rom Air-Shields2000-11-17
ATOM INFA WARMER V-505 (K002355)Atom Medical Corp2000-10-10
INCUWARMER (K971366)Hill-Rom, Inc.1998-01-05
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 (K972885)Fisher & Paykel Electronics , Ltd.1997-10-30
BABYTHERM 8004 BABYTHERM 8010 (K971198)Drager, Inc.1997-10-03
ACCUTEMP-PROBE (K970686)Kentec Medical, Inc.1997-08-25
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER (K971695)Fisher & Paykel Electronics , Ltd.1997-07-28
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) (K971461)Fisher & Paykel Electronics , Ltd.1997-07-16
INFANT RADIANT WARMER - MODELS IW910 AND IW920 (K970432)Fisher & Paykel Electronics , Ltd.1997-05-07
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) (K970074)Hill-Rom, Inc.1997-04-03
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) (K964401)Ludlow Technical Products1997-02-06
FIRST TOUCH DISPOSABLES TEMPERATURE PROBES (K950422)First Touch Disposables, Inc.1997-01-23
INFANT WARMER SYSTEM (K963058)Ohmeda Medical1996-10-01
ACCUTEMP PROBE (K960080)Kentec Medical, Inc.1996-05-01
TEMPERATURE PROBE-TP250 (K952801)Contour Medical Technology, Inc.1996-04-04
TEMPERATURE PROBE-TP150 (K952800)Contour Medical Technology, Inc.1996-04-04
TEMPERATURE PROBE-TP550 (K952805)Contour Medical Technology, Inc.1996-04-04
TEMPERATURE PROBE-TP350 (K952803)Contour Medical Technology, Inc.1996-04-04
TEMPERATURE PROBE-TP650 (K952807)Contour Medical Technology, Inc.1996-04-04
TEMPERATURE PROBE-TP450 (K952804)Contour Medical Technology, Inc.1996-04-04
DRAGER INFANT RADIANT WARMERN RH600 (K953489)Drager, Inc.1996-02-09
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE (K950143)Astral, Ltd.1995-09-25
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE (K946005)Astral, Ltd.1995-09-25
RW RESUCITAIRE INFANT RADIANT WARMER (K940951)Air-Shields, Inc.1995-05-03
DISPOSABLE TEMPERATURE PROBE COVER (K942905)Arbo Medical, Inc.1995-02-27
STABILET (K942904)Hill-Rom, Inc.1994-09-16
U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE (K934677)U.S. Medical Corp.1994-07-05
4002 INFANT SCALE FOR INCUBATORS AND WARMERS (K935609)Scale-Tronix, Inc.1994-07-01
INFANT WARMER (K931529)Medix I.C.S.A.1994-03-11
KLEAR-TEMP (K926030)Cas Medical Systems, Inc.1994-02-24
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO (K925006)Deroyal Industries, Inc.1994-01-31
ADVANTAGE (K921547)Kci1993-07-23
OHIO INFANT WARMER SYSTEM (K921766)Ohmeda Medical1993-04-23
VSI 1000 (K912921)Vitaltrends Technology, Inc.1992-10-30
THERMAL PROBE COVER (K915831)Vermont Medical, Inc.1992-06-08
STABILET INFANT RADIANT WARMER MODEL 2000C (K913945)Hill-Rom, Inc.1992-02-12
PATIENT WARMER MODEL 100C (K910915)Developmed Corp.1991-07-16
PREEMICARE SERIES 2000 INFANT WARMER (K885350)Preemicare Corp.1989-08-07
MODEL WC-115 MOBILE BASSINET (K884285)Gempco, Inc.1988-12-22
MODEL WC-107 MOBILE NEWBORN BED (K884283)Gempco, Inc.1988-12-22
MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET (K884280)Gempco, Inc.1988-12-22
ACCUTEMP PLUS (K881670)Sentry Medical Products, Inc.1988-11-22
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM (K884160)Ohmeda Medical1988-11-21
SPECIAL PROCEDURES BASE UNIT MODEL 500 (K881713)Gempco, Inc.1988-07-12
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS (K875270)Air-Shields, Inc.1988-01-19
WARM WEIGH MODELS I-20/W-30 INFANT SCALE (K872742)Air-Shields, Inc.1987-10-20
MTC XI UL (K871178)Aragona Medical, Inc.1987-10-09
NTH 101 UL (K871177)Aragona Medical, Inc.1987-10-09
BIRTHING ROOM WARMER (K871594)Air-Shields, Inc.1987-06-05
MODEL 10200 PREMATURE INFANT INCUBATOR (K862921)Rotem Industries C/O Medsys, Inc.1987-04-01
YSI MODEL 801 (K865012)Yellow Springs Instrument Co., Inc.1987-03-04
OHMEDA AUXILIARY POWER SYSTEM (K863208)Ohmeda Medical1986-10-03
DELIVERY ROOM WARMER (K861781)Air-Shields, Inc.1986-07-15
NEOCARE MODEL 800 INFANT RADIANT WARMER (K853926)Draeger Medical, Inc.1986-02-26
NEO SHIELD (K852943)Gaymar Industries, Inc.1985-11-08
OHMEDA HEAT REFLECTING PATCH (K853351)Ohmeda Medical1985-10-17
NEOGUARD REFLECTOR (K853794)Cas Medical Systems, Inc.1985-10-16
OHMEDA 5000 INFANT WARMER SYSTEM (K851449)Ohmeda Medical1985-06-07
BORNING NEONATAL RESUSCITATOIN CENTER (K850069)Borning Corp.1985-05-30
INFANT RADIANT WARMER (K840792)Hatch Bio Medical1984-05-25
INFANT WARMER (K833802)Kinetic Concepts, Inc.1984-04-05
OHIO 3000 INFANT WARMER SYSTEM (K840857)Ohio Medical Products1984-03-23
OHIO 3300 INFANT WARMER SYSTEM (K840858)Ohio Medical Products1984-03-23
AMEDA NEONATAL RESUSCITATION UNIT- (K832637)Egnell, Inc.1983-12-22
RESUSCITAIRE (K830748)Vickers America Medical Corp.1983-06-22
SAGE 2200 STERILE SPECIMEN CONTAINER (K813408)Sage Products, Inc.1982-01-25
WARMING LISTHTS #96H & 96HT (K812745)J. H. Emerson Co.1981-11-02
OHIO RADIANT WARMER (K802365)Ohio Medical Products1980-10-23
TEMP-GUARD TM (K790948)Gordon Consultants, Inc.1979-09-24
INFANT CARE SYSTEM (K790137)Narco Air-Shields1979-03-06

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Every clearance here is in the API, with alerts when new ones post.