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U.S. Department of Health and Human Services

Product Classification

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Device pump, infusion, insulin bolus
Regulation Description Infusion pump.
Definition The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Physical State The device is worn directly on the body. It is constructed of a variety of polymeric materials. Stainless steel is used in springs.
Technical Method The device contains the insulin in a reservoir attached to a pumping mechanism. The pump delivers a discrete bolus volume to the patient on demand. There are no means of providing continuous infusion.
Target Area Subcutaneous tissue. The device is generally targeted for use on the abdomen, buttocks, or other location acceptable for insulin delivery and device placement.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOPP
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions [http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209337.pdf] 
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible