# K143482: xevonta dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Avitum AG
- Decided: Mar 1, 2016 after 449 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071518 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100334: Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811, B. Braun Avitum AG (2010) Summary page 4.
- K071518: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers, B. Braun Medizintechnologie GmbH (2007) Summary page 4.

## Indications for use
The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.

Source page: https://510kreport.com/device/K143482
Methodology: https://510kreport.com/methodology