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suitcase kidney hemodialysis system
Union Carbide
Summary: The Suitcase Kidney Hemodialysis System is a portable dialysis device designed for increased patient mobility. Key evidence highlights its safety and efficiency in maintaining acceptable creatinine and urea clearances.
FDA Clearance Information
Pathway
510K
Number
K781405 ↗
Decision Date
December 7, 1978
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The Suitcase Kidney Hemodialysis System was cleared by the FDA through the 510(k) pathway on December 7, 1978. It is manufactured by Union Carbide and classified as a Class 2 device.
What It Is
The Suitcase Kidney Hemodialysis System is a portable hemodialysis device designed to provide renal replacement therapy for patients with kidney failure. It incorporates a microprocessor-controlled mechanism to ensure efficient dialysis in a compact form, enhancing patient mobility.
Clinical Applications
This device is commonly used in scenarios where patients require dialysis while traveling or in settings where traditional dialysis equipment is impractical. It is particularly beneficial for home hemodialysis patients seeking increased mobility.
Evidence Summary
The available literature includes four studies published between 1978 and 1981, comprising various study types such as RCTs and case series. These studies collectively evaluate the device's performance and patient outcomes.
Reported Outcomes
Published studies report that the Suitcase Kidney Hemodialysis System maintains acceptable clearances of creatinine and urea, indicating effective dialysis. The system's portability and efficiency have been positively evaluated in both bench and field tests.
Safety Profile
Reported complications include minimal adverse events, with studies indicating that the system is safe for use in both hospital and travel settings. No significant safety concerns were highlighted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies and the dated nature of the research, with the most recent study published in 1981. Further research is needed to evaluate long-term outcomes and modern clinical applications.
Frequently Asked Questions
What are the clinical indications for Suitcase Kidney Hemodialysis System?
The device is indicated for patients requiring hemodialysis, particularly those seeking portable solutions for travel or home use.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective clearance of creatinine and urea, demonstrating the system's efficacy in providing dialysis.
What complications have been reported?
Safety data from evidence indicate minimal complications, with the system being deemed safe for use in various settings.
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.