FDA Product Code FJK: Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Leading manufacturers include Fresenius Medical Care Renal Therapies Group, LLC, Diality, Inc. and Vital Healthcare Sdn. Bhd..
FDA 510(k) Cleared Set, Tubing, Blood, With And Without Anti-regurgitation Valve Devices (Product Code FJK)
About Product Code FJK - Regulatory Context
510(k) Submission Activity
76 total 510(k) submissions under product code FJK since 1977, with 76 receiving FDA clearance (average review time: 154 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for FJK submissions have been consistent, averaging 145 days recently vs 154 days historically.
FJK devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →