FDA Product Code FMT: Warmer, Infant Radiant
Preventing neonatal hypothermia is critical in the care of preterm and sick newborns. FDA product code FMT covers radiant infant warmers used in neonatal intensive care units and delivery rooms.
These devices use infrared radiant heat delivered from an overhead heater to maintain the thermal environment of newborns during resuscitation, procedures, and stabilization, while allowing full access to the infant for clinical care.
FMT devices are Class II medical devices, regulated under 21 CFR 880.5130 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Ohmeda Medical, Contour Medical Technology, Inc. and Air-Shields, Inc..
92
Total
92
Cleared
159d
Avg days
1979
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
57d
recently vs 160d historically
FDA 510(k) Cleared Warmer, Infant Radiant Devices (Product Code FMT)
92 devices
Cleared
Jan 17, 2025
Babyroo TN300
Draeger Medical Systems, Inc.
General Hospital
57d
Cleared
May 30, 2023
Babyroo TN300
Draeger Medical Systems, Inc.
General Hospital
118d
Cleared
Mar 02, 2022
Giraffe Omnibed Carestation CS1
Datex-Ohmeda, Inc.
General Hospital
114d
Cleared
Feb 12, 2021
Panda iRes Warmer, Giraffe Warmer
Ge Healthcare
General Hospital
241d
Cleared
Apr 02, 2020
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
Deroyal Industries, Inc.
General Hospital
55d
Cleared
Jan 21, 2020
Hydro-Temp Neonatal Skin Temperature Probe Cover
Deroyal Industries, Inc.
General Hospital
237d
Cleared
Aug 17, 2018
NuBorne Infant Warmer
International Biomedical
General Hospital
276d
Cleared
Feb 05, 2013
GIRAFFE AND PANDA WARMERS
Ohmeda Medical
General Hospital
104d
Cleared
Nov 02, 2012
RESUSCITAIRE WITH AUTOBREATH
Draeger Medical Systems, Inc.
General Hospital
245d
Cleared
Oct 02, 2012
GIRAFFE AND PANDA WARMERS
Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
General Hospital
64d
Cleared
Sep 14, 2012
LULLABY TM WARMER
Wipro GE Healthcare Private, Ltd.
General Hospital
105d
Cleared
Jul 06, 2012
SUNFLOWER WARNER
Atom Medical Corporation
General Hospital
100d
Cleared
Apr 16, 2009
MODIFICATION TO: GIRAFFE AND PANDA WARMER
Ohmeda Medical
General Hospital
30d
Cleared
Aug 27, 2007
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
Ohmeda Medical
General Hospital
24d
Cleared
Jul 11, 2007
GIRAFFE AND PANDA WARMER
Ohmeda Medical
General Hospital
153d
Cleared
Jan 05, 1998
INCUWARMER
Hill-Rom, Inc.
General Hospital
266d
Cleared
Oct 30, 1997
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
Fisher & Paykel Electronics , Ltd.
General Hospital
86d
Cleared
Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
Drager, Inc.
General Hospital
186d
Cleared
Aug 25, 1997
ACCUTEMP-PROBE
Kentec Medical, Inc.
General Hospital
181d
Cleared
Jul 28, 1997
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
Fisher & Paykel Electronics , Ltd.
General Hospital
81d
Cleared
Jul 16, 1997
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
Fisher & Paykel Electronics , Ltd.
General Hospital
86d
Cleared
May 07, 1997
INFANT RADIANT WARMER - MODELS IW910 AND IW920
Fisher & Paykel Electronics , Ltd.
General Hospital
92d
Cleared
Apr 03, 1997
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
Hill-Rom, Inc.
General Hospital
85d
Cleared
Feb 06, 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
Ludlow Technical Products
General Hospital
94d
About Product Code FMT - Regulatory Context
510(k) Submission Activity
92 total 510(k) submissions under product code FMT since 1979, with 92 receiving FDA clearance (average review time: 159 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - FMT Product Code
Recent submissions under FMT have taken an average of 57 days to reach a decision - down from 160 days historically, suggesting improved FDA processing for this classification.
FMT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →