FDA Product Code FMZ: Incubator, Neonatal
Leading manufacturers include Datex-Ohmeda, Inc., Mom Incubators Limited and Dr?gerwerk AG & Co KGaA.
FDA 510(k) Cleared Incubator, Neonatal Devices (Product Code FMZ)
About Product Code FMZ - Regulatory Context
510(k) Submission Activity
85 total 510(k) submissions under product code FMZ since 1978, with 85 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FMZ have taken an average of 230 days to reach a decision - up from 132 days historically. Manufacturers should account for longer review timelines in current project planning.
FMZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →