FDA Updates 510(k) Guidance for Hemodialysis Blood Tubing Sets

The FDA on Thursday issued a revised final guidance setting out what manufacturers should include in 510(k) premarket notifications for hemodialysis blood tubing sets, the arterial and venous lines that carry a patient's blood to the dialyzer and back during treatment.

The guidance, from the Center for Devices and Radiological Health, supersedes a document dated April 23, 2008. According to its guidance history, the FDA issued the changes under its Level 2 guidance procedures. The agency said the update harmonizes the document with its guidance on the ISO 10993-1 biocompatibility standard and makes other minor updates, primarily removing outdated submission format information now contained in the 510(k) eSTAR electronic template. Like other FDA guidance, it is nonbinding, and comments can be submitted at any time under docket FDA-2026-D-1877.

Scope and testing

The guidance covers devices under 21 CFR 876.5820 with product codes FJK, for blood tubing sets with and without anti-regurgitation valves, and KOC, for hemodialysis blood circuit accessories. It does not apply to tubing or devices used for vascular access, such as hemodialysis catheters, or to tubing used for peritoneal dialysis.

The FDA recommends testing three or more tubing sets of each model a company intends to market. Recommended tests include:

• Pressure leak testing at up to 1.5 times the maximum labeled positive and negative pressures.
• Endurance testing of the pump segment at maximum labeled blood flow rates and pressures, and of any injection ports.
• Tensile testing of joints and materials, and tests showing the clamps can occlude the tubing.
• Tests of whether pressure transducer protectors resist leakage at up to twice the maximum labeled pressure.
• Kink-resistance testing after repeated clamping, particularly in the post-pump segment.

The agency also recommends running each tubing set on every compatible dialysis delivery system named in the labeling with a blood analog fluid for four hours at 37 degrees Celsius to show the tubing does not kink.

Biocompatibility, sterility and labeling

The guidance treats blood tubing sets as externally communicating devices in long-term contact with circulating blood, because of cumulative exposure in patients with chronic kidney disease. Where a manufacturer cannot point to a legally marketed device using identical materials and manufacturing methods, the FDA lists ten biocompatibility endpoints to evaluate, from cytotoxicity to carcinogenicity, or a justification for not testing them. Material descriptions should include colorants and plasticizers such as DEHP.

The document recommends that sets be sterile with a sterility assurance level of 1 x 10-6 and be tested for pyrogens, and that expiration dates be supported by performance and package integrity testing on aged samples. It notes that the FDA's amended quality system regulation, which incorporates ISO 13485:2016, took effect on February 2, 2026.

On labeling, the FDA recommends color coding the arterial tubing connectors red and the venous connectors blue, and including a warning that significant hemolysis of red blood cells can occur in kinked tubing, especially in the post-pump arterial segment.