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 Draeger Medical Systems, Inc., Ge Healthcare and Datex-Ohmeda, Inc..
List of Warmer, Infant Radiant devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Warmer, Infant Radiant devices (product code FMT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →