Product Classification

• Device: pump, infusion, insulin
• Regulation Description: Infusion pump.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: LZG
• 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 Standard

• 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

Guidance Documents

• Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions  
• Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps

Third Party Review

Not Third Party Eligible