# K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 19, 2006 after 90 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: 6 generations back to K001283 (2001). 14 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030974: Exeltra High Flux Dialyzer, Models 150 & 170, Baxter Healthcare Corp (2003) Summary page 1.
- K050525: Nxstage System One, Nxstage Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210 (2009), 20 descendants of its own
- K082414: Optiflux F250NR, Model 0500325E (2008), 16 descendants of its own
- K123262: Optiflux Ultra Dialyzer (2014), 13 descendants of its own
- K152367: Optiflux dialyzer (2015), 12 descendants of its own
- K162488: Optiflux dialyzer (2017), 9 descendants of its own

## Indications for use
Hemodialysis with Xenium dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Source page: https://510kreport.com/device/K062079
Methodology: https://510kreport.com/methodology