Cleared Traditional

K231125 - 2008T BlueStar Hemodialysis Machine

K231125 is an FDA 510(k) clearance for 2008T BlueStar Hemodialysis Machine, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K231125 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
230d
Days
Class 2
Risk

K231125 is an FDA 510(k) clearance for the 2008T BlueStar Hemodialysis Machine. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on December 6, 2023 after a review of 230 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Medical Care Renal Therapies Group, LLC devices

FDA 510(k) Submission Details - K231125

510(k) Number K231125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 131d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K231125.
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
K232803 · Nxstage Medical, Inc. · Mar 2024
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K232171 · Tecnoideal America · Feb 2024
5008X Hemodialysis System
K231534 · Fresenius Medical Care · Feb 2024
Tablo® Hemodialysis System
K233335 · Outset Medical, Inc. · Dec 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · Baxter Healthcare Corporation · Sep 2023
VersiHD with GuideMe software
K230632 · Nxstage Medical, Inc. · Aug 2023