# DEN190042: Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

- Pathway: De Novo (Direct)
- Applicant: Baxter Healthcare Corporation
- Decided: Aug 28, 2020 after 347 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K261399: Elisio™-HX (2026), 0 descendants of its own

## Indications for use
The Theranova 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. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.

Source page: https://510kreport.com/device/DEN190042
Methodology: https://510kreport.com/methodology