Cleared Traditional

2008T BlueStar Hemodialysis Machine

K231125 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology

Dec 2023

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K231125 is an FDA 510(k) clearance for the 2008T BlueStar Hemodialysis Machine, 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 6, 2023, 230 days after receiving the submission on April 20, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K231125 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2023
Decision Date	December 06, 2023
Days to Decision	230 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