Product Classification

• Device: accessories, pump, infusion
• Regulation Description: Infusion pump.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MRZ
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• 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: Eligible
• 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
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Guidance Document

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

Third Party Review

Not Third Party Eligible