510(k) Report

FDA product code · Gastroenterology and urology

Hemodialyzer With Expanded Solute Removal Profile

QAXClass II21 CFR 876.5862510(k) required2 decisions since 20200 recalls

2 FDA decisions since 2020. No recall names this code. The most-cited predicate is DEN190042, named by 1 later device.

A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of QAX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QAX

1in 2020

2020: 12026 (partial year): 1
2007high 1 (2020) · low 0 (2007)2026

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

2023: 12025: 3
2007high 3 (2025) · low 0 (2007)2025

MAUDE reports naming product code QAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—00
20220—00
20230—01
20240—00
20250—03
20261—0—
FIG. 1 — QAX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QAX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do QAX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN190042Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerBaxter Healthcare Corporation · 20201cites it

Which QAX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K261399Elisio™-HXNipro Medical Corporation · 20261generation

What has FDA decided in QAX lately?

  • K261399Elisio™-HXNipro Medical Corporation · 2026
  • DEN190042Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerBaxter Healthcare Corporation · 2020

All 2 QAX decisions →