Product Classification

• Device: dialyzer, high permeability with or without sealed dialysate system
• Regulation Description: High permeability hemodialysis system.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: KDI
• Submission Type: 510(k)
• Regulation Number: 876.5860
• 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 8637:2010 Cardiovascular implants and extracorporeal systems - Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators
• 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 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