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..
FDA 510(k) Cleared Warmer, Infant Radiant Devices (Product Code FMT)
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 Review Time
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 →