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hemodialysis system
Fhk
Summary: The hemodialysis system by Fhk is a device cleared by the FDA for dialysis treatment. It is primarily used for blood purification in patients with renal failure. Key evidence highlights its potential in reducing inflammatory cytokines like IL-6.
FDA Clearance Information
Pathway
510K
Number
K813432 ↗
Decision Date
June 23, 1982
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The hemodialysis system by Fhk was cleared through the FDA 510k pathway on June 23, 1982. It is classified as a Class 2 device under product code FKP.
What It Is
The hemodialysis system is a medical device designed for extracorporeal blood purification, primarily used in patients with renal failure. It functions by removing waste products and excess fluid from the blood, mimicking kidney function.
Clinical Applications
This device is commonly used in clinical settings for patients requiring renal replacement therapy due to chronic kidney disease or acute kidney injury. It is utilized in both hospital and outpatient dialysis centers.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies. These studies span from 2020 to 2024, focusing on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the hemodialysis system effectively reduces levels of inflammatory cytokines such as IL-6, which may contribute to improved patient outcomes in systemic inflammatory conditions. Additionally, the device is noted for its ease of use in self-care settings, potentially reducing healthcare costs.
Safety Profile
Reported complications include device-related adverse events, although specific details are not extensively covered in the provided studies. Overall, the device is considered safe for use in both clinical and home settings.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials directly comparing this system to other hemodialysis devices. Further research is needed to fully understand long-term outcomes and potential complications.
Frequently Asked Questions
What are the clinical indications for hemodialysis system?
The hemodialysis system is indicated for patients requiring renal replacement therapy, such as those with chronic kidney disease or acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report effective reduction of inflammatory cytokines like IL-6 and highlight the device's potential for use in self-care settings.
What complications have been reported?
Reported complications include device-related adverse events, though specific details are limited in the available studies.
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.