# K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Feb 20, 2009 after 63 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: 7 generations back to K001283 (2001). 15 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2006) Summary page 2.

## Most influential descendants
- 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
- K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (2023), 6 descendants of its own
- K093120: Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170 (2010), 6 descendants of its own

## Indications for use
Hemodialysis with Xenium XPH 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/K083778
Methodology: https://510kreport.com/methodology