Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

DEN190042 is the FDA 510(k) clearance record for Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer, a class II device, cleared for Baxter Healthcare Corporation on 2020-08-28 under FDA product code QAX (Hemodialyzer With Expanded Solute Removal Profile). FDA's definition for product code QAX 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...". FDA records list 570 510(k) clearances for Baxter Healthcare Corporation, from 1977-01-06 to 2025-12-16. As of 2026-09-10, FDA records show no recalls naming DEN190042.