De Novo · Granted
GrantedTheranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · QAX Hemodialyzer With Expanded Solute Removal Profile
Granted on Aug 28, 2020 as a new device type through De Novo after a 347-day review. 1 later device descends from it.
- Decided
- Aug 28, 2020
- Review
- 347 days
- Class
- Class II
- Product code
- QAX
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN190042 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerBaxter Healthcare Corporation · 2020
- Descendant · cites it directly · 0 of its ownK261399 Elisio™-HXNipro Medical Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K261399Elisio™-HXNipro Medical Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation | 2020 | — |
| +1 | K261399 | Elisio™-HX | Nipro Medical Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QAX device
- #1 K261399 Elisio™-HXscore 11.7 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261399 | Elisio™-HX | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K261399 (Nipro Medical Corporation, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QAX devicesQAX Hemodialyzer With Expanded Solute Removal Profile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QAX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QAX
Too few QAX 510(k)s in any year since 2007 to give a median.
Recalls per year · QAX
No recall names QAX since 2007.
Adverse event reports per year · QAX
3in 2025
MAUDE reports naming product code QAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190042 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190042: Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190042
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026