Cleared Traditional

multiFiltratePRO System

K220281 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology

Dec 2022

Decision

318d

Days

Class 2

Risk

About This 510(k) Submission

K220281 is an FDA 510(k) clearance for the multiFiltratePRO System, 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 December 16, 2022, 318 days after receiving the submission on February 1, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K220281 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2022
Decision Date	December 16, 2022
Days to Decision	318 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