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, Draeger Medical Systems, Inc. and Deroyal Industries, 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
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
Oct 01, 1996
INFANT WARMER SYSTEM
Ohmeda Medical
General Hospital
56d
Cleared
Jan 31, 1994
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
Deroyal Industries, Inc.
General Hospital
486d
Cleared
Apr 23, 1993
OHIO INFANT WARMER SYSTEM
Ohmeda Medical
General Hospital
374d
Cleared
Nov 21, 1988
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
Ohmeda Medical
General Hospital
48d
Cleared
Oct 03, 1986
OHMEDA AUXILIARY POWER SYSTEM
Ohmeda Medical
General Hospital
45d
Cleared
Feb 26, 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
Draeger Medical, Inc.
General Hospital
155d
Cleared
Oct 17, 1985
OHMEDA HEAT REFLECTING PATCH
Ohmeda Medical
General Hospital
66d
Cleared
Jun 07, 1985
OHMEDA 5000 INFANT WARMER SYSTEM
Ohmeda Medical
General Hospital
57d
Cleared
Apr 05, 1984
INFANT WARMER
Kinetic Concepts, Inc.
General Hospital
156d
Cleared
Mar 23, 1984
OHIO 3000 INFANT WARMER SYSTEM
Ohio Medical Products
General Hospital
28d
Cleared
Mar 23, 1984
OHIO 3300 INFANT WARMER SYSTEM
Ohio Medical Products
General Hospital
28d
Cleared
Oct 23, 1980
OHIO RADIANT WARMER
Ohio Medical Products
General Hospital
24d
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 →