Product Classification

• Device: set, administration, intravascular
• Regulation Description: Intravascular administration set.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FPA
• Submission Type: 510(k)
• Regulation Number: 880.5440
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
• ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
• 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 Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]
• Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.