# K131935: Elisio-H Hemodialyzer, Elisio-M Hemodialyzer

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Dec 20, 2013 after 176 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: 10 generations back to K001283 (2001). 18 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122347: Elisio-H and Elisio-M Hemodialyzers, Nipro Medical Corporation (2013) Summary page 1.

## Most influential descendants
- 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 an ELISIO™-M hemodialyzer 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/K131935
Methodology: https://510kreport.com/methodology