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dbb-06 hemodialysis delivery system
Nikkiso
Summary: The dbb-06 hemodialysis delivery system by Nikkiso is designed for hemodialysis treatment. It is FDA 510k cleared and supported by 10 studies, focusing on its efficacy and safety.
FDA Clearance Information
Pathway 510K
Number K152938 ↗
Decision Date March 18, 2016
Product Code KDI
Device Class Class 2
Evidence 0 studies
The dbb-06 hemodialysis delivery system was cleared by the FDA through the 510k pathway on March 18, 2016. It is manufactured by Nikkiso and classified as a Class 2 device.
What It Is
The dbb-06 is a hemodialysis delivery system used in the treatment of patients with renal failure. It facilitates the removal of waste products and excess fluid from the blood, mimicking kidney function.
Clinical Applications
This device is commonly used in clinical settings for patients requiring hemodialysis due to chronic kidney disease or acute kidney injury. It is integral in managing fluid and electrolyte balance.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and observational studies, conducted between 2022 and 2024.
Reported Outcomes
Published studies report that the dbb-06 system effectively reduces markers of inflammation and improves solute clearance in hemodialysis patients. It is associated with improved patient outcomes in terms of dialysis efficacy.
Safety Profile
Reported complications include potential inflammatory responses, although the use of ultrapure dialysate with the system may mitigate these effects. No significant adverse events were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the dbb-06 system. Further research is needed to explore long-term outcomes and compare its efficacy with other dialysis systems.
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 due to renal failure, including chronic kidney disease and acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report improved solute clearance and reduced inflammation markers in patients using the dbb-06 system.
What complications have been reported?
Reported complications include inflammatory responses, though these may be reduced with ultrapure dialysate use.
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.