QAXClass II

Hemodialyzer With Expanded Solute Removal Profile

21 CFR 876.5862 / Gastroenterology, Urology

QAX is the FDA product code for Hemodialyzer With Expanded Solute Removal Profile, a class II device type, regulated under 21 CFR 876.5862. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2026-07-28, and no recalls.

Classification record

Product code: QAX
Device name: Hemodialyzer With Expanded Solute Removal Profile
FDA definition: 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).
Regulation: 21 CFR 876.5862
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code QAX

By decision year

2 clearances under product code QAX with a decision year between 2020 and 2026, 2020 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QAX by decision year
Year	Clearances
2020	1
2026	1

Applicants with the most clearances

Product code QAX

Applicants holding the most 510(k) clearances under product code QAX
Applicant	Clearances
Baxter Healthcare Corporation	1
Nipro Medical Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QAX

Recent recalls

Product code QAX

FDA records show no recalls under product code QAX.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)