Cleared Traditional

K243237 - 2008T HD SYS. CDX BLUESTAR (191124) (FDA 510(k) Clearance)

Also includes:
2008T HD SYS. CDX W/bibag BLUESTAR (191126) 2008T HD SYS. W/O CDX BLUESTAR (191128) 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243237 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
246d
Days
Class 2
Risk

K243237 is an FDA 510(k) clearance for the 2008T HD SYS. CDX BLUESTAR (191124). 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 June 13, 2025 after a review of 246 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

Submission Details

510(k) Number K243237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2024
Decision Date June 13, 2025
Days to Decision 246 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
116d slower than avg
Panel avg: 130d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 342
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