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Sansin Tubing Sets for Hemodialysis

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202796

by Jiangxi Sanxin Medtec Co., Ltd.

Identifiers

510(k) Number
K202796 FDA 510(k)
FDA Product Code
FJK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sansin Tubing Sets for Hemodialysis are sterile, single-use blood tubing sets designed for hemodialysis procedures. These sets include tubing with and without anti-regurgitation valves, facilitating the safe and efficient transfer of blood between the patient and the dialysis machine.

These tubing sets are supplied in sterile packaging and are intended for single-use only. They are classified as Class II medical devices under FDA regulations (21 CFR 876.5820) and have received FDA 510(k) clearance, along with CE marking under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The sets are available in multiple reference codes as listed in the registration data, ensuring compatibility with various hemodialysis systems.

Frequently asked questions

Are these tubing sets compatible with most hemodialysis machines, or do I need to check specific models before purchasing?

The Sansin Tubing Sets for Hemodialysis are designed with multiple reference codes to ensure compatibility with a wide range of hemodialysis systems. While the exact models aren’t listed, the broad registration numbers (e.g., 3002974635, 3032828299) suggest they support diverse machines. However, it’s always best to verify compatibility with your specific dialysis machine’s requirements before use, as variations in connectors or flow rates may exist.

How should I store these tubing sets to maintain their sterility before use?

The tubing sets are supplied in sterile packaging, which must remain unopened until use. Storage should be in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Avoid refrigeration or freezing, as these conditions could compromise the integrity of the packaging or the tubing material. Always follow the manufacturer’s instructions for storage duration and conditions.

Can these tubing sets be reused, or are they strictly for single-use only?

These tubing sets are explicitly labeled as single-use only. Reusing them poses risks of contamination, bloodborne pathogen exposure, or mechanical failure, which could compromise patient safety. Each set is designed for one hemodialysis procedure and should be discarded after use in accordance with medical waste protocols.

What regulatory approvals do these tubing sets hold, and how does that affect their use in clinical settings?

The Sansin Tubing Sets for Hemodialysis have received FDA 510(k) clearance, indicating they are classified as substantially equivalent to a predicate device under 21 CFR 876.5820. They also carry CE marking under the Medical Device Directive (MDD) and Medical Device Regulation (MDR), demonstrating compliance with European standards. These approvals confirm the device meets U.S. and EU safety and performance requirements, but clinicians should still adhere to local guidelines for hemodialysis procedures and device integration.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jiangxi Sanxin Medtec Co., Ltd.

Sources (2)

  • FDA 510(k) K202796 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026