DeviceClearance

Product code QAX— Gastroenterology, Urology

ELISIO-HX

Classification name
Hemodialyzer With Expanded Solute Removal Profile
Device class
Class 2
Regulation
21 CFR 876.5862
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code QAX under 21 CFR 876.5862, via openFDA

Market context for product code QAX

FDA has cleared 2 devices under product code QAX between 2020 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QAX

Recent clearances under product code QAX

Data sourced from openFDA. This site is unofficial and independent of the FDA.