FDA Product Code ONW: Hemodialysis System For Home Use
To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients.
Leading manufacturers include Quanta Dialysis Technologies, Ltd..
FDA 510(k) Cleared Hemodialysis System For Home Use Devices (Product Code ONW)
About Product Code ONW - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code ONW since 2011, with 4 receiving FDA clearance (average review time: 505 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ONW have taken an average of 92 days to reach a decision - down from 642 days historically, suggesting improved FDA processing for this classification.
ONW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →