# K261399: Elisio™-HX

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Jul 28, 2026 after 90 days
- Product code: QAX (Hemodialyzer With Expanded Solute Removal Profile)
- Device class: 2
- Regulation: 21 CFR 876.5862
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN190042 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190042: Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer, Baxter Healthcare Corporation (2020) Summary page 5.

## Indications for use
The ELISIO™-HX dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 KDa) that may play a pathologic role in the uremic clinical syndrome. This dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for this dialyzer and the set should represent less than 10% of the patient's blood volume.

Source page: https://510kreport.com/device/K261399
Methodology: https://510kreport.com/methodology