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Nikkiso
Summary: Blood tubing lines for hemodialysis by Nikkiso are used in dialysis to transport blood between the patient and the dialysis machine. Key evidence highlights their role in preventing coagulation and ensuring biocompatibility.
FDA Clearance Information
Pathway
510K
Number
K242479 ↗
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 via 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 part of the extracorporeal circuit used in hemodialysis. They facilitate the transport of blood from the patient to the dialysis machine and back, ensuring efficient waste removal and fluid balance.
Clinical Applications
Commonly used in chronic and acute hemodialysis settings, these tubing lines are essential for patients requiring renal replacement therapy. They are integral to the dialysis process, ensuring safe and effective blood circulation.
Evidence Summary
The literature includes 15 studies, ranging from 2006 to 2024, covering various aspects of blood tubing lines, including coagulation prevention and biocompatibility. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the blood tubing lines effectively prevent coagulation during hemodialysis sessions. They are also noted for their biocompatibility, which is crucial for minimizing adverse reactions during treatment.
Safety Profile
Reported complications include the formation of white thrombus within the tubing lines and potential leakage of electrical current, which poses a safety risk, especially for patients with central dialysis catheters.
Evidence Limitations
The evidence is limited by the small number of studies directly addressing long-term outcomes and safety. Further research is needed to explore the impact of different materials and designs on clinical efficacy and safety.
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 dialysis machine.
What outcomes have been reported in clinical studies?
Studies report effective prevention of coagulation and high biocompatibility, which are critical for successful hemodialysis sessions.
What complications have been reported?
Safety data indicate potential complications such as white thrombus formation and electrical current leakage, particularly in patients 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.