Cleared Traditional

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)

K242053 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology

Mar 2025

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K242053 is an FDA 510(k) clearance for the FX CorAL 40 (F00009214); FX CorAL 50 (F00009215), 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 March 21, 2025, 252 days after receiving the submission on July 12, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K242053 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2024
Decision Date	March 21, 2025
Days to Decision	252 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