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dbb-06 hemodialysis delivery system
Nikkiso
Summary: The dbb-06 is a hemodialysis delivery system by Nikkiso, primarily used for kidney replacement therapy. Key evidence highlights its role in reducing inflammation with ultrapure dialysate.
FDA Clearance Information
Pathway
510K
Number
K091978 ↗
Decision Date
March 25, 2010
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The dbb-06 hemodialysis delivery system was cleared by the FDA via the 510(k) pathway on March 25, 2010. It is manufactured by Nikkiso and classified as a Class 2 device.
What It Is
The dbb-06 is a hemodialysis delivery system designed to provide efficient dialysis treatment by delivering ultrapure dialysate. It is intended for use in patients requiring kidney replacement therapy.
Clinical Applications
Commonly used in clinical settings for patients with end-stage renal disease requiring hemodialysis. It is particularly relevant in scenarios where ultrapure dialysate is needed to minimize inflammatory responses.
Evidence Summary
The literature includes 10 studies, covering a range of study types such as RCTs and prospective studies, with publication years spanning from 2022 to 2024.
Reported Outcomes
Published studies report that the use of ultrapure dialysate in the dbb-06 system can decrease dialysate contamination and reduce inflammatory markers in hemodialysis patients. The system's efficacy in solute clearance and ultrafiltration is also highlighted.
Safety Profile
Reported complications include potential inflammatory responses if dialysate purity is compromised. However, the use of ultrapure dialysate in the dbb-06 system is associated with reduced inflammation.
Evidence Limitations
There is limited research directly comparing the dbb-06 with other hemodialysis systems. Further studies are needed to explore long-term outcomes and the impact of ultrapure dialysate on patient quality of life.
Frequently Asked Questions
What are the clinical indications for dbb-06 hemodialysis delivery system?
The dbb-06 is indicated for use in patients requiring hemodialysis as part of kidney replacement therapy.
What outcomes have been reported in clinical studies?
Studies report reduced inflammation and effective solute clearance with the use of ultrapure dialysate in the dbb-06 system.
What complications have been reported?
Safety data indicate potential inflammatory responses if dialysate purity is not maintained, though ultrapure dialysate use mitigates this risk.
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.