Cleared Traditional

K243505 - 5008X Hemodialysis System

K243505 is an FDA 510(k) clearance for 5008X Hemodialysis System, 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 199-day FDA review.

K243505 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
199d
Days
Class 2
Risk

K243505 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 Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 30, 2025 after a review of 199 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 - K243505

510(k) Number K243505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date May 30, 2025
Days to Decision 199 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
68d slower than avg
Panel avg: 131d · This submission: 199d
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 K243505.
Purema H Hemoconcentrator - Pediatric
K243920 · Medica USA, Inc. · Sep 2025
AK 98 Dialysis Machine (955607)
K250508 · Vantive US Healthcare, LLC · Aug 2025
2008T HD SYS. CDX BLUESTAR (191124)
K243237 · Fresenius Medical Care Renal Therapies Group, LLC · Jun 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · NIKKISO CO., LTD. · May 2025
DHF 0.2 Hemoconcentrator (DHF 02)
K243264 · Sorin Group Italia S.R.L. · Apr 2025
FX CorAL 40 (F00009214)
K242053 · Fresenius Medical Care Renal Therapies Group, LLC · Mar 2025