Product Classification

• Device: pump, infusion, insulin
• Regulation Description: Infusion pump.
• Regulation Medical Specialty: General Hospital
• Review Panel: Clinical Chemistry
• Product Code: LZG
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 880.5725
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-422 AAMI TIR38:2019
  Medical device safety assurance case guidance
• 6-482 AAMI TIR101:2021
  Fluid delivery performance testing for infusion pumps
• 13-81 IEEE Std 11073-10419:2015
  Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
• 13-91 IEEE ISO 11073-10419 First edition 2016-06-15
  Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump

Guidance Document

• Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible