Cleared Traditional

5008X Hemodialysis System (K231534) - FDA 510(k) Clearance

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

K231534 · Fresenius Medical Care · Gastroenterology & Urology device
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Feb 2024
Decision
248d
Days
Class 2
Risk

K231534 is an FDA 510(k) clearance for the 5008X Hemodialysis System. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care (Waltham, US). The FDA issued a Cleared decision on February 2, 2024 after a review of 248 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.

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Submission Details

510(k) Number K231534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date February 02, 2024
Days to Decision 248 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
118d slower than avg
Panel avg: 130d · This submission: 248d
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 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K231534.
Tablo® Hemodialysis System
K232776 · Outset Medical, Inc. · May 2024
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
K232803 · Nxstage Medical, Inc. · Mar 2024
Purema® H Hemoconcentrator (EtO Sterilized)
K232171 · Tecnoideal America · Feb 2024
2008T BlueStar Hemodialysis Machine
K231125 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2023
Tablo® Hemodialysis System
K233335 · Outset Medical, Inc. · Dec 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · Baxter Healthcare Corporation · Sep 2023