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Nipro Blood Tubing Set For Hemodialysis With Transducer Protectors And Priming Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010264

by Nipro Medical Corp.

Identifiers

510(k) Number
K010264 FDA 510(k)
FDA Product Code
FIB 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 Nipro Blood Tubing Set for Hemodialysis is a medical device designed to facilitate the extracorporeal circulation of blood during hemodialysis procedures. It includes integrated transducer protectors to maintain monitoring while reducing exposure to the dialysis machine, as well as a priming set for system preparation.

This device is supplied as a disposable unit and is intended for single-use applications. It is regulated under FDA 510(k) clearance, identified by K010264, and falls under the device class 2 category for dialysis transducer protectors.

Frequently asked questions

What is the primary purpose of the Nipro Blood Tubing Set?

This device is designed to facilitate the extracorporeal circulation of blood during hemodialysis procedures. It includes a priming set to assist with system preparation before treatment begins.

Does this tubing set include protection for the dialysis machine?

Yes, the set features integrated transducer protectors. These components are designed to maintain necessary monitoring functions while simultaneously reducing the exposure of the dialysis machine to the blood circuit.

Is this device intended for reuse after cleaning?

No, the Nipro Blood Tubing Set is supplied as a disposable unit and is intended strictly for single-use applications to ensure patient safety and prevent cross-contamination.

What is the regulatory status of this hemodialysis tubing set?

This device is regulated under FDA 510(k) clearance, identified by submission number K010264. It is classified as a class 2 device under the category for dialysis transducer protectors.

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. Sources consulted: NiproSet™ Blood Tubing Set - nipro-group.com, Blood Tubing Set and Accessories - NIPRO CORPORATION, PDF 510(k) Summary of Safety and Effectiveness for Nipro® Set Blood Tubing ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corp.

Sources (1)

  • FDA 510(k) K010264 24 fields · synced Oct 6, 2026