Cleared Traditional

multiFlux 130 (F00013123); multiFlux 160 (F00013124)

K252459 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology

Feb 2026

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K252459 is an FDA 510(k) clearance for the multiFlux 130 (F00013123); multiFlux 160 (F00013124), 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 February 10, 2026, 189 days after receiving the submission on August 5, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K252459 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2025
Decision Date	February 10, 2026
Days to Decision	189 days
Submission Type	Traditional
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