📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use in hemodialysis treatment to provide extracorporeal blood purification.
- For removal of metabolic waste products and excess fluid from the blood of patients with inadequate kidney function.
- For use with compatible hemodialysis equipment, dialyzers, blood tubing, dialysate and water systems according to the manufacturer's labeling.
Clinical Applications
- Maintenance hemodialysis for patients with end-stage kidney disease.
- Hemodialysis for patients with acute kidney injury when renal replacement therapy is clinically indicated.
- Delivery and monitoring of dialysate during intermittent hemodialysis.
- Support of extracorporeal blood purification in a dialysis center or other appropriately equipped clinical setting.
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.
Practical Considerations
- The system must be used with compatible dialyzers, blood tubing sets, dialysate concentrates, treated water and other accessories specified in the manufacturer's instructions.
- Treatment requires vascular access, such as an arteriovenous fistula, arteriovenous graft or dialysis catheter; the access is not part of the delivery system.
- The device is operated by trained dialysis personnel who monitor blood flow, dialysate flow, pressures, fluid removal and treatment alarms.
- MRI compatibility should not be assumed. Because the system contains electrical and mechanical components, it should remain outside the MRI environment unless the manufacturer provides specific MR labeling.
- Use is limited by standard hemodialysis contraindications and precautions, including inability to establish safe vascular access, severe hemodynamic instability or unsafe fluid and electrolyte conditions.
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.