FDA Product Code QAX: Hemodialyzer With Expanded Solute Removal Profile
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 Compared With Standard High-flux Hemodialyzers Of The High Permeability Hemodialysis System Classification (21 Cfr §876.5860), Including Solutes At The Upper End Of The middle Molecular Weight Range (0.5 Kda To 60 Kda).
Leading manufacturers include Baxter Healthcare Corporation and Nipro Medical Corporation.
2
Total
1
Cleared
219d
Avg days
2020
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
90d
recently vs 347d historically
FDA 510(k) Cleared Hemodialyzer With Expanded Solute Removal Profile Devices (Product Code QAX)
2 devices
Cleared
Jul 28, 2026
ELISIO™-HX
Nipro Medical Corporation
Gastroenterology & Urology
90d
Not Cleared
Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Baxter Healthcare Corporation
Gastroenterology & Urology
347d
About Product Code QAX - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QAX since 2020, with 1 receiving FDA clearance (average review time: 219 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QAX Product Code
Recent submissions under QAX have taken an average of 90 days to reach a decision - down from 347 days historically, suggesting improved FDA processing for this classification.
QAX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →