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dbb-06 pro hemodialysis delivery system dbb-06 pro
Nikkiso
Summary: The dbb-06 pro is a hemodialysis delivery system by Nikkiso, primarily used for renal replacement therapy. Key evidence highlights its role in improving dialysis efficiency.
FDA Clearance Information
Pathway
510K
Number
K242155 ↗
Decision Date
May 15, 2025
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The dbb-06 pro hemodialysis delivery system by Nikkiso was cleared via the FDA 510(k) pathway on May 15, 2025. It is classified as a Class 2 device under product code KDI.
What It Is
The dbb-06 pro is a hemodialysis delivery system designed to facilitate renal replacement therapy by removing waste products and excess fluid from the blood. It is intended for use in patients with renal failure.
Clinical Applications
Commonly used in dialysis centers, the dbb-06 pro is employed in scenarios requiring efficient blood purification, such as chronic kidney disease and acute kidney injury management.
Evidence Summary
The literature includes 10 studies, with a mix of study types such as RCTs and case series, spanning from 2022 to 2025. These studies explore various aspects of dialysis technology and patient outcomes.
Reported Outcomes
Published studies report improvements in dialysis efficiency and patient outcomes with the use of advanced hemodialysis systems. However, specific outcomes related to the dbb-06 pro are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with hemodialysis, such as vascular access issues and infection. Specific safety data for the dbb-06 pro is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific data on the dbb-06 pro's long-term efficacy and safety. Further research is needed to establish comprehensive outcomes and safety profiles specific to this device.
Frequently Asked Questions
What are the clinical indications for dbb-06 pro?
The dbb-06 pro is indicated for use in patients requiring hemodialysis, such as those with chronic kidney disease or acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report general improvements in dialysis efficiency, but specific outcomes for the dbb-06 pro are not detailed.
What complications have been reported?
Reported complications include general hemodialysis risks like vascular access issues and infection, but specific data for the dbb-06 pro is not provided.
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.