510(k) · Cleared
ClearedElisio™-HX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · QAX Hemodialyzer With Expanded Solute Removal Profile
Cleared on Jul 28, 2026 as substantially equivalent to DEN190042 (Baxter Healthcare Corporation, 2020) after a 90-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jul 28, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- QAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190042 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190042 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerBaxter Healthcare Corporation · 2020
- This deviceK261399 Elisio™-HXNipro Medical Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation | 2020 | — |
| 0 (this device) | K261399 | Elisio™-HX | Nipro Medical Corporation | 2026 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerSummary page 5…panded solute removal profile Regulation Number 876.5862 Product Code QAX Legally marketed predicate device (21 CFR 807.92(a)(3)) Predicate # DEN190042 Predicate Trade Name: Theranova Product Code: QAX Predicate # K260533 Predicate Trade Name: ELISIO™-H Product Co… | 2020 |
| † | K260533 | Elisio™-H | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2026, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261399: Elisio™-HX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261399
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026