# K100334: Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811

- Pathway: 510(k) (Special)
- Applicant: B. Braun Avitum AG
- Decided: Apr 22, 2010 after 76 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: 1 generation back to K071518 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071518: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers, B. Braun Medizintechnologie GmbH (2007) Summary page 1.

## Most influential descendants
- K143482: xevonta dialyzer (2016), 0 descendants of its own

## Indications for use
The Dlacap Polysulfone HiFlo 23 Hemodialyzer is dcsngned for single use in acute and chronic hemodialysis.

Source page: https://510kreport.com/device/K100334
Methodology: https://510kreport.com/methodology