21 C.F.R. § 880.5400
Neonatal incubator.
Cite as 21 C.F.R. § 880.5400 (2026)
(a)
Identification.
A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.
(b)
Classification.
Class II (performance standards).