Last synced on 27 January 2023 at 11:04 pm

Pump, Infusion, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.5725
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

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).

Pump, Infusion, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.5725
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

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).