FDA Product Code
FDA Product Code FMT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5130
510(k) Clearances — 92 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2025-01-17 | Traditional | PDF ↗ |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023-05-30 | Traditional | PDF ↗ |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 | Traditional | PDF ↗ |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021-02-12 | Traditional | PDF ↗ |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | Deroyal Industries, Inc. | 2020-04-02 | Traditional | PDF ↗ |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | 2020-01-21 | Traditional | PDF ↗ |
| K173516 | NuBorne Infant Warmer | International Biomedical | 2018-08-17 | Abbreviated | PDF ↗ |
| K123309 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical | 2013-02-05 | Traditional | PDF ↗ |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | 2012-11-02 | Traditional | PDF ↗ |
| K122267 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 | Special | PDF ↗ |
| K121625 | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | 2012-09-14 | Traditional | PDF ↗ |
| K120937 | SUNFLOWER WARNER | Atom Medical Corporation | 2012-07-06 | Traditional | PDF ↗ |
| K102227 | INFA WARMER I | Atom Medical Corporation | 2011-01-21 | Traditional | PDF ↗ |
| K101804 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010-07-21 | Special | PDF ↗ |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2009-04-16 | Special | PDF ↗ |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Ohmeda Medical | 2007-08-27 | Special | PDF ↗ |
| K070377 | GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2007-07-11 | Traditional | PDF ↗ |
| K060461 | V-505 INFA WARMER | Atom Medical, Inc. | 2006-04-28 | Special | PDF ↗ |
| K033040 | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | International Hospital Supply Co. | 2003-12-17 | Abbreviated | PDF ↗ |
| K020966 | RPI REPLACEMENT HEATING ELEMENTS | Replacement Parts Industries, Inc. | 2002-06-13 | Traditional | PDF ↗ |
| K020219 | RPI SKIN OR AIR TEMPERATURE PROBE | Replacement Parts Industries, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC | National Custom Ent., Inc. | 2001-09-10 | Traditional | PDF ↗ |
| K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER | Hill-Rom Air-Shields | 2000-11-17 | Special | PDF ↗ |
| K002355 | ATOM INFA WARMER V-505 | Atom Medical Corp | 2000-10-10 | Abbreviated | PDF ↗ |
| K971366 | INCUWARMER | Hill-Rom, Inc. | 1998-01-05 | Traditional | PDF ↗ |
| K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 | Fisher & Paykel Electronics , Ltd. | 1997-10-30 | Traditional | PDF ↗ |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | Drager, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K970686 | ACCUTEMP-PROBE | Kentec Medical, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | Fisher & Paykel Electronics , Ltd. | 1997-07-28 | Traditional | PDF ↗ |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) | Fisher & Paykel Electronics , Ltd. | 1997-07-16 | Traditional | PDF ↗ |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | Fisher & Paykel Electronics , Ltd. | 1997-05-07 | Traditional | PDF ↗ |
| K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) | Hill-Rom, Inc. | 1997-04-03 | Traditional | PDF ↗ |
| K964401 | KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) | Ludlow Technical Products | 1997-02-06 | Traditional | PDF ↗ |
| K950422 | FIRST TOUCH DISPOSABLES TEMPERATURE PROBES | First Touch Disposables, Inc. | 1997-01-23 | Traditional | PDF ↗ |
| K963058 | INFANT WARMER SYSTEM | Ohmeda Medical | 1996-10-01 | Traditional | PDF ↗ |
| K960080 | ACCUTEMP PROBE | Kentec Medical, Inc. | 1996-05-01 | Traditional | PDF ↗ |
| K952805 | TEMPERATURE PROBE-TP550 | Contour Medical Technology, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K952801 | TEMPERATURE PROBE-TP250 | Contour Medical Technology, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K952800 | TEMPERATURE PROBE-TP150 | Contour Medical Technology, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K952803 | TEMPERATURE PROBE-TP350 | Contour Medical Technology, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K952807 | TEMPERATURE PROBE-TP650 | Contour Medical Technology, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K952804 | TEMPERATURE PROBE-TP450 | Contour Medical Technology, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K953489 | DRAGER INFANT RADIANT WARMERN RH600 | Drager, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K950143 | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE | Astral, Ltd. | 1995-09-25 | Traditional | PDF ↗ |
| K946005 | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE | Astral, Ltd. | 1995-09-25 | Traditional | PDF ↗ |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | Air-Shields, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K942905 | DISPOSABLE TEMPERATURE PROBE COVER | Arbo Medical, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K942904 | STABILET | Hill-Rom, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K934677 | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE | U.S. Medical Corp. | 1994-07-05 | Traditional | PDF ↗ |
| K935609 | 4002 INFANT SCALE FOR INCUBATORS AND WARMERS | Scale-Tronix, Inc. | 1994-07-01 | Traditional | PDF ↗ |
| K931529 | INFANT WARMER | Medix I.C.S.A. | 1994-03-11 | Traditional | PDF ↗ |
| K926030 | KLEAR-TEMP | Cas Medical Systems, Inc. | 1994-02-24 | Traditional | PDF ↗ |
| K925006 | HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO | Deroyal Industries, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K921547 | ADVANTAGE | Kci | 1993-07-23 | Traditional | PDF ↗ |
| K921766 | OHIO INFANT WARMER SYSTEM | Ohmeda Medical | 1993-04-23 | Traditional | PDF ↗ |
| K912921 | VSI 1000 | Vitaltrends Technology, Inc. | 1992-10-30 | Traditional | PDF ↗ |
| K915831 | THERMAL PROBE COVER | Vermont Medical, Inc. | 1992-06-08 | Traditional | PDF ↗ |
| K913945 | STABILET INFANT RADIANT WARMER MODEL 2000C | Hill-Rom, Inc. | 1992-02-12 | Traditional | PDF ↗ |
| K910915 | PATIENT WARMER MODEL 100C | Developmed Corp. | 1991-07-16 | Traditional | PDF ↗ |
| K885350 | PREEMICARE SERIES 2000 INFANT WARMER | Preemicare Corp. | 1989-08-07 | Traditional | PDF ↗ |
| K884285 | MODEL WC-115 MOBILE BASSINET | Gempco, Inc. | 1988-12-22 | Traditional | PDF ↗ |
| K884283 | MODEL WC-107 MOBILE NEWBORN BED | Gempco, Inc. | 1988-12-22 | Traditional | PDF ↗ |
| K884280 | MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET | Gempco, Inc. | 1988-12-22 | Traditional | PDF ↗ |
| K881670 | ACCUTEMP PLUS | Sentry Medical Products, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K884160 | OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM | Ohmeda Medical | 1988-11-21 | Traditional | PDF ↗ |
| K881713 | SPECIAL PROCEDURES BASE UNIT MODEL 500 | Gempco, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K875270 | INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS | Air-Shields, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K872742 | WARM WEIGH MODELS I-20/W-30 INFANT SCALE | Air-Shields, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K871178 | MTC XI UL | Aragona Medical, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K871177 | NTH 101 UL | Aragona Medical, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K871594 | BIRTHING ROOM WARMER | Air-Shields, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K862921 | MODEL 10200 PREMATURE INFANT INCUBATOR | Rotem Industries C/O Medsys, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K865012 | YSI MODEL 801 | Yellow Springs Instrument Co., Inc. | 1987-03-04 | Traditional | PDF ↗ |
| K863208 | OHMEDA AUXILIARY POWER SYSTEM | Ohmeda Medical | 1986-10-03 | Traditional | PDF ↗ |
| K861781 | DELIVERY ROOM WARMER | Air-Shields, Inc. | 1986-07-15 | Traditional | PDF ↗ |
| K853926 | NEOCARE MODEL 800 INFANT RADIANT WARMER | Draeger Medical, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K852943 | NEO SHIELD | Gaymar Industries, Inc. | 1985-11-08 | Traditional | PDF ↗ |
| K853351 | OHMEDA HEAT REFLECTING PATCH | Ohmeda Medical | 1985-10-17 | Traditional | PDF ↗ |
| K853794 | NEOGUARD REFLECTOR | Cas Medical Systems, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K851449 | OHMEDA 5000 INFANT WARMER SYSTEM | Ohmeda Medical | 1985-06-07 | Traditional | PDF ↗ |
| K850069 | BORNING NEONATAL RESUSCITATOIN CENTER | Borning Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K840792 | INFANT RADIANT WARMER | Hatch Bio Medical | 1984-05-25 | Traditional | PDF ↗ |
| K833802 | INFANT WARMER | Kinetic Concepts, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K840858 | OHIO 3300 INFANT WARMER SYSTEM | Ohio Medical Products | 1984-03-23 | Traditional | PDF ↗ |
| K840857 | OHIO 3000 INFANT WARMER SYSTEM | Ohio Medical Products | 1984-03-23 | Traditional | PDF ↗ |
| K832637 | AMEDA NEONATAL RESUSCITATION UNIT- | Egnell, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K830748 | RESUSCITAIRE | Vickers America Medical Corp. | 1983-06-22 | Traditional | PDF ↗ |
| K813408 | SAGE 2200 STERILE SPECIMEN CONTAINER | Sage Products, Inc. | 1982-01-25 | Traditional | PDF ↗ |
| K812745 | WARMING LISTHTS #96H & 96HT | J. H. Emerson Co. | 1981-11-02 | Traditional | PDF ↗ |
| K802365 | OHIO RADIANT WARMER | Ohio Medical Products | 1980-10-23 | Traditional | PDF ↗ |
| K790948 | TEMP-GUARD TM | Gordon Consultants, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K790137 | INFANT CARE SYSTEM | Narco Air-Shields | 1979-03-06 | Traditional | PDF ↗ |
Product code FMT · Class II · General Hospital. Data: openFDA.