# K122347: Elisio-H and Elisio-M Hemodialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: May 1, 2013 after 271 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: 9 generations back to K001283 (2001). 17 ancestors in all.
5 later devices descend from it; 2 cite 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 1.
- K093120: Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170, Baxter Healthcare Corporation - Renal Division (2010) Summary page 1.

## Most influential descendants
- 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
- K160444: FB-U Hemodialyzer (2017), 0 descendants of its own

## Indications for use
Hemodialysis with an ELISIO-H or ELISIO-M hemadialyzer 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. The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.

Source page: https://510kreport.com/device/K122347
Methodology: https://510kreport.com/methodology