đź“Š Evidence-Based Reference
blood tubing lines for hemodialysis al series archloop blood tubing lines for hemodialysis c18 series al-adc-e u al-cdc-e u c18rdc-e u c18bdd-e u c18sfd-e u
Nikkiso
Summary: Blood tubing lines for hemodialysis by Nikkiso are used in dialysis to transport blood between the patient and the dialyzer. Key evidence highlights their role in preventing coagulation and ensuring biocompatibility.
FDA Clearance Information
Pathway
510K
Number
K242176 ↗
Decision Date
May 15, 2025
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The blood tubing lines for hemodialysis by Nikkiso were cleared through the FDA 510(k) pathway on May 15, 2025. They are classified as Class 2 devices under product code KOC.
What It Is
These blood tubing lines are integral components of the hemodialysis system, facilitating the transport of blood from the patient to the dialyzer and back. They are designed to minimize coagulation and ensure biocompatibility during dialysis sessions.
Clinical Applications
Commonly used in chronic and acute hemodialysis settings, these tubing lines are essential for patients requiring renal replacement therapy. They are particularly important in ensuring safe and effective blood circulation during dialysis.
Evidence Summary
The literature includes 15 studies, ranging from 2006 to 2024, encompassing various study types such as RCTs and case series. These studies focus on the safety, efficacy, and material properties of the tubing lines.
Reported Outcomes
Published studies report that the blood tubing lines effectively prevent coagulation during hemodialysis and maintain biocompatibility. They also highlight the importance of the tubing's physical properties in supporting next-generation sensor development.
Safety Profile
Reported complications include the potential for white thrombus formation and leakage of electrical current, particularly when central dialysis catheters are used. These issues underscore the need for careful monitoring during use.
Evidence Limitations
The evidence is limited by the small number of studies directly assessing long-term outcomes and safety. Further research is needed to explore the impact of tubing material on patient outcomes and to address the risk of electrical leakage.
Frequently Asked Questions
What are the clinical indications for blood tubing lines for hemodialysis?
These tubing lines are indicated for use in hemodialysis to facilitate blood transport between the patient and the dialyzer, ensuring effective renal replacement therapy.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of coagulation and maintenance of biocompatibility, with a focus on the tubing's role in supporting sensor development.
What complications have been reported?
Safety data indicate potential complications such as white thrombus formation and electrical leakage, particularly with central dialysis catheters.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.