đź“Š Evidence-Based Reference
phd personal hemodialysis instrument-1m101 phd water pre-treatment kit-1w605 phd hard plumbing kit-1w604 phd blood tub
Aksys
Summary: The phd personal hemodialysis instrument by Aksys is a dialysis-access device cleared by the FDA. It is primarily used for home hemodialysis. Key evidence highlights its role in managing end-stage kidney disease.
FDA Clearance Information
Pathway
510K
Number
K010131 ↗
Decision Date
March 26, 2002
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The phd personal hemodialysis instrument was cleared by the FDA via the 510(k) pathway on March 26, 2002. It is manufactured by Aksys and classified as a Class 2 medical device.
What It Is
The phd personal hemodialysis instrument is designed for home hemodialysis, allowing patients with end-stage kidney disease to perform dialysis independently. It includes a water pre-treatment kit and hard plumbing kit to facilitate the process.
Clinical Applications
This device is commonly used in home settings for patients with end-stage kidney disease who require regular dialysis. It provides an alternative to in-center dialysis, offering flexibility and convenience for patients.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, observational studies, and case series. The studies span from 2003 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the phd personal hemodialysis instrument is effective in managing end-stage kidney disease, with some evidence suggesting improved patient outcomes compared to traditional in-center dialysis. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with hemodialysis, such as infection and vascular access issues. The evidence does not provide detailed safety data specific to this device.
Evidence Limitations
The evidence lacks detailed efficacy and safety metrics specific to the phd personal hemodialysis instrument. Further research is needed to explore long-term outcomes and device-specific complications.
Frequently Asked Questions
What are the clinical indications for phd personal hemodialysis instrument?
The device is indicated for home hemodialysis in patients with end-stage kidney disease.
What outcomes have been reported in clinical studies?
Studies suggest improved patient outcomes with home hemodialysis, but specific metrics are not detailed.
What complications have been reported?
Reported complications include general hemodialysis risks such as infection and vascular access issues.
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.