21 C.F.R. § 880.5725

Infusion pump.

Last amended: 2016Year: 2026Length: 98 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 880.5725 (2026)

(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. (b) Classification. Class II (performance standards).
21 C.F.R. § 880.5725: Infusion pump. | Justis AI