📋 FDA Reference
Acute Hemodialysis Trays
Intermed
Summary: Acute hemodialysis trays are used in dialysis procedures to manage kidney failure. They are utilized by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K833139 ↗
Decision Date ?
December 22, 1983
Product Code ?
KNZ
Device Class ?
Class 2
Evidence ?
0 studies
The acute hemodialysis trays by Intermed were cleared through the FDA 510(k) pathway on December 22, 1983. They are classified as Class 2 devices under product code KNZ.
What It Is
Acute hemodialysis trays are pre-packaged kits containing the necessary components for performing hemodialysis, a procedure to filter waste and excess fluids from the blood when the kidneys are not functioning properly. These trays typically include items such as catheters, tubing, and dialyzers. The trays are designed to streamline the setup process, ensuring that all necessary components are sterile and readily available.
FDA-Cleared Indications
- Use during hemodialysis for patients with kidney failure.
- Use when dialysis is required to manage fluid, electrolyte, and waste-product abnormalities associated with impaired kidney function.
Clinical Applications
- Setting up hemodialysis for patients with acute kidney injury.
- Setting up hemodialysis for patients with chronic kidney failure or end-stage kidney disease.
- Supporting hospital-based hemodialysis treatments.
- Providing sterile, organized components for a dialysis procedure.
Practical Considerations
- The tray configuration may vary and can include blood tubing, access components, connectors, and other dialysis supplies; verify the contents before use.
- Confirm compatibility with the prescribed dialysis machine, dialyzer, vascular access, tubing connections, and other equipment.
- Use only with appropriate trained personnel and maintain aseptic technique to reduce the risk of bloodstream infection.
- The kit does not replace clinical assessment, dialysis prescriptions, vascular-access management, or monitoring of fluid and electrolyte status.
- MRI safety depends on the individual components and any metallic parts; review the product labeling before bringing an unopened or opened tray into the MRI environment.
Frequently Asked Questions
What is acute hemodialysis trays used for?
They are used to perform hemodialysis, a procedure to filter waste from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use these trays in hospital and dialysis center settings.
What are the FDA-cleared indications?
They are indicated for use in patients requiring hemodialysis due to kidney failure, including both acute and chronic conditions.
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.