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Nipro Blood Tubing Set With Transducer Protector And Priming Set (A201-A219 +3 …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072024

by Nipro Medical Corp.

Identifiers

510(k) Number
K072024 FDA 510(k)
FDA Product Code
FJK FDA 510(k)
Models / Variants
A201-A219 FDA 510(k)
V801-V806 FDA 510(k)
5m9634 FDA 510(k)
5m9693 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)

This device is a Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, designed for extracorporeal blood access during hemodialysis procedures. It includes a blood tubing set integrated with a transducer protector and priming set to facilitate safe and accurate blood flow management during dialysis treatments.

The set is supplied as a single-use, sterile disposable device, intended for use in hemodialysis environments. Models A201–A219 and V801–V806 are configured for compatibility with specific dialysis machines, while 5M9634 and 5M9693 denote additional variants. It has received FDA 510(k) clearance under regulation 876.5820 and is classified as Class II. No MRI safety information is specified.

Frequently asked questions

What is the primary use of the Nipro Blood Tubing Set with Transducer Protector and Priming Set in a clinical setting?

This device is designed specifically for extracorporeal blood access during hemodialysis procedures. It ensures safe and accurate blood flow management by integrating a blood tubing set with a transducer protector and priming set, which helps maintain proper fluid dynamics during treatment.

Are there different models available, and how do they relate to compatibility with dialysis machines?

Yes, the device comes in multiple models: A201–A219, V801–V806, 5M9634, and 5M9693. These models are configured to be compatible with specific dialysis machines, meaning each variant is tailored for use with particular equipment to ensure proper functionality and safety during hemodialysis.

Is the Nipro Blood Tubing Set with Transducer Protector and Priming Set intended for single-use or reuse?

The device is explicitly labeled as a single-use, sterile disposable, meaning it is designed for one-time use only in hemodialysis procedures. Reuse is not recommended or supported by the manufacturer.

How should this device be stored to maintain its integrity before use?

While the data does not specify exact storage conditions, as a sterile disposable medical device, it should be stored in a clean, dry environment, protected from contamination, extreme temperatures, and direct sunlight. Always follow the manufacturer’s instructions (if available) or standard medical device storage protocols to preserve sterility and functionality.

What regulatory pathway was followed for FDA clearance of this device?

The Nipro Blood Tubing Set received FDA 510(k) clearance under regulation 876.5820, classified as a Class II device. The clearance was granted as *Substantially Equivalent* (SESE) through a Special 510(k) review process, with the advisory committee involved being the Gastroenterology and Urology (GU) Panel.

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, Nipro Blood Tubing Set With Transducer Protector and Priming Set, Model ..., PDF Nipro Blood Tubing Set With Transducer Protector and Priming Set, Model ...

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) K072024 24 fields · synced Oct 6, 2026