Cleared Special

multiFlux 1000 (F00012408)

K240394 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology

May 2024

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K240394 is an FDA 510(k) clearance for the multiFlux 1000 (F00012408), a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 31, 2024, 113 days after receiving the submission on February 8, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K240394 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2024
Decision Date	May 31, 2024
Days to Decision	113 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860