# K260533: Elisio™-H

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Mar 19, 2026 after 30 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: 12 generations back to K001283 (2001). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131935: Elisio-H Hemodialyzer, Elisio-M Hemodialyzer, Nipro Medical Corporation (2013) Summary page 5.
- K140191: Elisio-H Hemodialyzer, Nipro Medical Corporation (2014) Summary page 5.
- K203062: Optiflux Series of Dialyzers F160NR,  F180NR, F200NR, Fresenius Medical Care Renal Therapies Group, LLC (2020) Summary page 5.

## Indications for use
ELISIO™-H dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K260533
Methodology: https://510kreport.com/methodology