Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Issue Date: July 23, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Gastroenterology-Urology
Status: Final

Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA’s recommendations on information to support premarket notification (510(k)) submissions for hemodialysis blood tubing sets. The recommendations are intended to promote consistency and facilitate efficient review of hemodialysis blood tubing set submissions.

Download the Guidance Document