Anesthesiology
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- Subpart B—Biological StainsCFR Sub-Part
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Pump, Infusion, Insulin
- Page Type
- Product Code
- Regulation Medical Specialty
- General Hospital
- Review Panel
- Chemistry
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 880.5725
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 880.5725 Infusion pump
§ 880.5725 Infusion pump.
(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).