đź“‹ FDA Reference
Vital Tubing Sets for Hemodialysis
Vital Healthcare Sdn. Bhd.
Summary: Vital tubing sets for hemodialysis are used in dialysis procedures to transport blood between the patient and the dialysis machine. They are primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K251341 ↗
Decision Date ?
January 16, 2026
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The vital tubing sets for hemodialysis by Vital Healthcare Sdn. Bhd. were cleared via the FDA 510k pathway on January 16, 2026. This device is classified as Class 2 under product code FJK.
What It Is
The vital tubing sets for hemodialysis are medical devices designed to facilitate the transport of blood from a patient to a dialysis machine and back. They are composed of biocompatible materials to ensure patient safety and minimize the risk of infection. These tubing sets are essential components of the hemodialysis circuit, ensuring efficient blood flow and dialysis treatment.
FDA-Cleared Indications
- Use during hemodialysis procedures for patients requiring renal replacement therapy.
- Use to provide blood flow between the patient and the hemodialysis machine during treatment.
Clinical Applications
- Connecting a patient’s vascular access to the blood inlet of a hemodialysis machine.
- Returning treated blood from the dialysis machine to the patient.
- Supporting hemodialysis treatment for patients with severely reduced or absent kidney function.
- Use in acute or chronic hemodialysis settings when the tubing set is compatible with the dialysis machine and treatment system.
Practical Considerations
- The tubing set must match the hemodialysis machine, dialyzer, connectors and prescribed treatment configuration.
- Available tubing lengths, internal diameters and connector configurations may vary by model; staff should verify compatibility before use.
- The set is handled as a sterile, single-use blood-contacting component unless its labeling states otherwise. Inspect packaging, tubing and connections before use.
- Correct priming, connection and securement are required to reduce air entry, blood loss, leaks and contamination.
- These tubing sets are not themselves implanted devices and do not provide vascular access. MRI considerations depend on the complete dialysis system and any connected components; follow the product labeling and facility MRI policy.
Frequently Asked Questions
What is vital tubing sets for hemodialysis used for?
They are used to transport blood between the patient and the dialysis machine during hemodialysis procedures.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use these devices in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The tubing sets are indicated for use in hemodialysis procedures for patients requiring renal replacement therapy.
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.