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Xevonta Dialyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K143482

by B.Braun Avitum AG

Identifiers

510(k) Number
K143482 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 Xevonta Dialyzer is a high-permeability dialyzer designed for hemodialysis, classified under the nomenclature for dialyzers with or without a sealed dialysate system. Its X-shaped design and optimized pore structure enhance clearance efficiency for middle molecules and uremic toxins while maintaining albumin retention, supporting effective toxin removal during dialysis sessions.

Supplied as a single-use device, the Xevonta Dialyzer is intended for use in hemodialysis and hemodiafiltration (HDF) settings. It is available in multiple surface-area sizes, including a 2.3 m² variant, and requires sterile handling per standard medical device protocols. The device carries FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for high-permeability dialyzers. Storage and usage follow manufacturer guidelines to ensure sterility and performance integrity.

Frequently asked questions

What types of dialysis treatments is the Xevonta Dialyzer approved for, and how does its design support those treatments?

The Xevonta Dialyzer is approved for use in both hemodialysis (HD) and hemodiafiltration (HDF) treatments. Its X-shaped design and optimized pore structure enhance clearance efficiency for middle molecules and uremic toxins, which is particularly beneficial in HDF where higher convective transport is desired. This design also helps maintain albumin retention, ensuring effective toxin removal while preserving essential blood components during dialysis sessions.

Is the Xevonta Dialyzer intended for single-use or can it be reused? How should it be handled to maintain sterility?

The Xevonta Dialyzer is explicitly designed for single-use only. To maintain sterility, it must be handled using standard sterile medical device protocols, including proper packaging integrity checks before opening and adherence to manufacturer guidelines for storage and usage. Reuse is not recommended or supported by the manufacturer.

What surface-area sizes are available for the Xevonta Dialyzer, and how might this affect treatment selection?

The Xevonta Dialyzer is available in multiple surface-area sizes, including a 2.3 m² variant. Larger surface areas generally allow for more efficient clearance of toxins and waste products during dialysis, which can be particularly useful for patients with higher metabolic demands or those requiring extended treatment times. The specific size chosen may depend on patient-specific factors like body size, dialysis prescription, and clinical needs.

What regulatory pathways has the Xevonta Dialyzer followed, and what does this mean for its use in clinical settings?

The Xevonta Dialyzer has obtained FDA 510(k) clearance and MDR authorization, indicating it meets regulatory standards for high-permeability dialyzers in the U.S. and EU markets, respectively. This means it has undergone rigorous review to demonstrate safety and performance, allowing clinicians and facilities to use it with confidence in hemodialysis and HDF settings. The regulatory approvals also ensure compliance with quality and safety standards for medical devices.

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: Xevonta® Dialyzer - BBraunUSA.com, xevonta - B. Braun, xevonta | B. Braun

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
B.Braun Avitum AG
FDA Applicant
B. Braun Avitum AG

Sources (2)

  • FDA 510(k) K143482 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 22, 2026