📋 FDA Reference
Acute Hemodialysis Trays
Packaging Technologies
Summary: Acute hemodialysis trays are used in dialysis procedures to manage acute kidney failure. They are typically utilized by nephrologists and dialysis nurses in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844612 ↗
Decision Date ?
December 17, 1984
Product Code ?
KNZ
Device Class ?
Class 2
Evidence ?
0 studies
The acute hemodialysis trays by Packaging Technologies were cleared through the FDA 510(k) pathway on December 17, 1984. This device is classified as a Class 2 medical device under product code KNZ.
What It Is
Acute hemodialysis trays are pre-packaged kits containing all necessary components for performing hemodialysis, a procedure to filter waste and excess fluid from the blood when the kidneys are not functioning properly. These trays help streamline the setup process, ensuring that all required tools are readily available and sterile. They are designed for use in acute settings where rapid intervention is needed.
FDA-Cleared Indications
- For use in setting up hemodialysis procedures for patients with acute kidney failure.
- For temporary dialysis support when rapid hospital-based treatment is required.
Clinical Applications
- Setting up acute hemodialysis in hospitalized patients with sudden loss of kidney function.
- Supporting hemodialysis in intensive care units and other acute-care settings.
- Providing prepackaged sterile components for dialysis treatment setup.
- Managing excess fluid and waste products in the blood when kidney function is temporarily inadequate.
Practical Considerations
- Confirm that the tray contents are complete, sterile, intact, and within the labeled expiration date before use.
- Verify compatibility with the dialysis machine, blood tubing configuration, vascular access, dialyzer, and other equipment used by the facility.
- Tray contents, component sizes, and configurations may vary by model; follow the specific product instructions for use.
- These trays are supplies for setting up dialysis and do not replace clinical assessment, dialysis-machine operation, vascular-access management, or monitoring by trained staff.
- The tray itself is not an implanted device and is not evaluated for MRI safety; MRI considerations apply to any patient-access device or other equipment used during treatment.
Frequently Asked Questions
What is acute hemodialysis trays used for?
They are used for performing hemodialysis in patients with acute kidney failure.
What specialties typically use this device?
Nephrologists and dialysis nurses in hospital settings, especially in ICUs and emergency departments.
What are the FDA-cleared indications?
For use in patients with acute kidney failure requiring immediate dialysis.
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.