# K093120: Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation - Renal Division
- Decided: Feb 17, 2010 after 138 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: 8 generations back to K001283 (2001). 16 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2009) Summary page 2.

## Most influential descendants
- K122347: Elisio-H and Elisio-M Hemodialyzers (2013), 5 descendants of its own
- K131935: Elisio-H Hemodialyzer, Elisio-M Hemodialyzer (2013), 3 descendants of its own
- K131381: Elisio-H Hemodialyzer (2013), 2 descendants of its own
- K140191: Elisio-H Hemodialyzer (2014), 1 descendant of its own
- K260533: Elisio™-H (2026), 0 descendants of its own

## Indications for use
Hemodialysis with Xenium XPM 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/K093120
Methodology: https://510kreport.com/methodology