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FB-U Hemodialyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160444

by Nipro Medical Corporation

Identifiers

510(k) Number
K160444 FDA 510(k)
FDA Product Code
KDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5860 FDA 510(k)
Regulation Number
876.5860 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FB-U Hemodialyzer is a high-permeability dialyzer designed for extracorporeal blood treatment, functioning as an artificial kidney. It is intended for use in hemodialysis to remove waste products, excess fluids, and electrolytes from the blood of patients with acute or chronic renal failure, as well as for detoxification in cases of poisoning or drug overdose.

This device is supplied as a single-use, sterile, cylindrical hemodialyzer housed in a rigid container. It is classified under FDA regulation 876.5860 as a Class II medical device and has received FDA 510(k) clearance (K160444) and MDR authorization. The FB-U Hemodialyzer is intended for use in clinical settings, including hospitals and dialysis centers, and must be handled according to sterile medical device protocols.

Frequently asked questions

What clinical conditions is the FB-U Hemodialyzer primarily used to treat, and how does it function in those cases?

The FB-U Hemodialyzer is designed for extracorporeal blood treatment, serving as an artificial kidney to manage patients with acute or chronic renal failure. It removes waste products, excess fluids, and electrolytes from the blood through hemodialysis. Additionally, it is used for detoxification in cases of poisoning or drug overdose, helping to clear harmful substances from the bloodstream.

Is the FB-U Hemodialyzer intended for single-use or can it be reused? How is it packaged and stored?

The FB-U Hemodialyzer is explicitly designed for single-use only and comes sterile in a rigid container. Since it is a sterile medical device, it must be handled according to sterile protocols. Storage should follow manufacturer guidelines to maintain sterility and functionality until use.

What regulatory pathways has the FB-U Hemodialyzer undergone, and where is it authorized for use?

The FB-U Hemodialyzer has received FDA 510(k) clearance (K160444) and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. It is classified as a Class II medical device under FDA regulation 876.5860 and is intended for use in clinical settings like hospitals and dialysis centers.

Are there multiple sizes or models of the FB-U Hemodialyzer, and if so, how are they differentiated?

The provided data lists multiple FEI numbers (e.g., 3002806443, 3002807196), which typically correspond to different sizes, configurations, or batch identifiers for the FB-U Hemodialyzer. While exact size variations (e.g., membrane surface area, blood flow rates) aren’t detailed here, these identifiers suggest the device may be available in multiple configurations to accommodate different patient needs or dialysis protocols.

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: FB-U Hemodialyzer 510 (k) K160444 - FDA.report, FB-U Hemodialyzer (K160444) — FDA 510 (k) | Innolitics, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (2)

  • FDA 510(k) K160444 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026