# K131381: Elisio-H Hemodialyzer

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Dec 19, 2013 after 219 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). 25 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 28 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.
- K926005: Fresenius Hemoflow, Various Models, Fresenius USA, Inc. (1994) Summary page 1.
- K082414: Optiflux F250NR, Model 0500325E, Fresenius Medical Care North America (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K100276: Fresenius Hemoflow. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree 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

## Indications for use
Hemodialysis with an ELISIOTM-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy isjudged to be inadequate. It also may be indicated in the treatmuent of patients intoxicated wit 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/K131381
Methodology: https://510kreport.com/methodology