FDA Product Code KDJ: Set, Administration, For Peritoneal Dialysis, Disposable
Leading manufacturers include Baxter Healthcare Corporation, Baxter Healthcare and Fresenius Medical Care Renal Therapies Group, LLC.
FDA 510(k) Cleared Set, Administration, For Peritoneal Dialysis, Disposable Devices (Product Code KDJ)
About Product Code KDJ - Regulatory Context
510(k) Submission Activity
113 total 510(k) submissions under product code KDJ since 1977, with 113 receiving FDA clearance (average review time: 107 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under KDJ have taken an average of 50 days to reach a decision - down from 108 days historically, suggesting improved FDA processing for this classification.
KDJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →