Cleared Traditional

2008T BlueStar Hemodailysis Machine

K222952 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology

Oct 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K222952 is an FDA 510(k) clearance for the 2008T BlueStar Hemodailysis 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 October 27, 2022, 30 days after receiving the submission on September 27, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K222952 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2022
Decision Date	October 27, 2022
Days to Decision	30 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