Product Classification

• Device: system, dialysate delivery, single patient
• Regulation Description: Hemodialysis system and accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FKP
• Submission Type: 510(k)
• Regulation Number: 876.5820
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-16 (1998) Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
• IEC 60601-2-16 Edition 3.0 2008-04 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• IEC 60601-2-16 (Third edition - 2008) Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1
• AAMI/ANSI
• ISO 13959 Second edition 2009-04-15 Water for haemodialysis and related therapies
• ISO 23500 First edition 2011-05-15 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
• ISO 11663 First edition 2009-04-15 Quality of dialysis fluid for haemodialysis and related therapies
• IEC 60601-2-16 Edition 4.0 2012-03 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
• AAMI/ANSI/ISO 13959:2009 Water for hemodialysis and related therapies
• AAMI/ANSI/ISO 23500:2011 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
• AAMI/ANSI/ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies
• AAMI/ANSI/ISO 60601-2-16:2008 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

Guidance Documents

• Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
• Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final

Third Party Review

Not Third Party Eligible