Product code FMT
- Device name
- Warmer, Infant Radiant
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5130
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2025-01-17 |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023-05-30 |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021-02-12 |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | Deroyal Industries, Inc. | 2020-04-02 |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | 2020-01-21 |
| K173516 | NuBorne Infant Warmer | International Biomedical | 2018-08-17 |
| K123309 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical | 2013-02-05 |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | 2012-11-02 |
| K122267 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 |
| K121625 | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | 2012-09-14 |
| K120937 | SUNFLOWER WARNER | Atom Medical Corporation | 2012-07-06 |
| K102227 | INFA WARMER I | Atom Medical Corporation | 2011-01-21 |
| K101804 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010-07-21 |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2009-04-16 |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Ohmeda Medical | 2007-08-27 |
| K070377 | GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2007-07-11 |
| K060461 | V-505 INFA WARMER | Atom Medical, Inc. | 2006-04-28 |
| K033040 | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | International Hospital Supply Co. | 2003-12-17 |
| K020966 | RPI REPLACEMENT HEATING ELEMENTS | Replacement Parts Industries, Inc. | 2002-06-13 |
| K020219 | RPI SKIN OR AIR TEMPERATURE PROBE | Replacement Parts Industries, Inc. | 2002-04-12 |
| 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 |
| K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER | Hill-Rom Air-Shields | 2000-11-17 |
| K002355 | ATOM INFA WARMER V-505 | Atom Medical Corp | 2000-10-10 |
| K971366 | INCUWARMER | Hill-Rom, Inc. | 1998-01-05 |
| 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 |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | Drager, Inc. | 1997-10-03 |
| K970686 | ACCUTEMP-PROBE | Kentec Medical, Inc. | 1997-08-25 |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | Fisher & Paykel Electronics , Ltd. | 1997-07-28 |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) | Fisher & Paykel Electronics , Ltd. | 1997-07-16 |
Related GUDID Devices#
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|---|---|---|---|
| 10889483587904 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| 10889483587881 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| 10190752181199 | Airlife™ | AirLife Finland Oy | 2021-03-05 |
| 10190752181205 | Airlife | AirLife Finland Oy | 2021-02-26 |
| 10190752106116 | AirLife™ | AirLife Finland Oy | 2021-01-28 |
| 10190752106123 | AirLife™ | AirLife Finland Oy | 2021-01-28 |
| 10813150021149 | PerformancePlus™ | GRAPHIC CONTROLS ACQUISITION CORP | 2018-03-02 |
| 10813150020579 | TenderTrode Plus™ | GRAPHIC CONTROLS ACQUISITION CORP | 2018-03-02 |
| 10885403252259 | AirLife | Carefusion Finland 320 Oy | 2016-10-17 |
| 10885403252907 | AirLife | Carefusion Finland 320 Oy | 2016-10-17 |
| 10884527006571 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| 20884527006530 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| 20884527006547 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| 20884527006554 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| 20884527006561 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| 09420012409386 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-10 |
| 09420012400963 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012433152 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012433145 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012418722 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012414823 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012409324 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012409003 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012400932 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 10817522010045 | Ameritus | KENTEC MEDICAL, INC. | 2016-08-02 |
| 10817522010199 | AccuTemp Probe | KENTEC MEDICAL, INC. | 2016-08-02 |
| 10817522010212 | AccuTemp Probe | KENTEC MEDICAL, INC. | 2016-08-02 |
| 10817522010236 | AccuTemp Probe | KENTEC MEDICAL, INC. | 2016-08-02 |
| 10817522010038 | Ameritus | KENTEC MEDICAL, INC. | 2016-08-02 |
| 10817522010021 | Ameritus | KENTEC MEDICAL, INC. | 2016-08-02 |