# K243505: 5008X Hemodialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 30, 2025 after 199 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K921456 (1994). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231534: 5008X Hemodialysis System, Fresenius Medical Care (2024) Summary page 6.
- K231125: 2008T BlueStar Hemodialysis Machine, Fresenius Medical Care Renal Therapies Group, LLC (2023) Summary page 6.
- K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line, Fresenius Medical Care Renal Therapies Group, LLC (2020) Summary page 6.

## Most influential descendants
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own

## Recalls of this device
- Aug 10, 2026 · Class II · Z-3087-2026: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Aug 10, 2026 · Class II · Z-3086-2026: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Aug 10, 2026 · Class II · Z-3084-2026: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Aug 10, 2026 · Class II · Z-3085-2026: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- May 11, 2026 · Class II · Z-2702-2026: Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
- Oct 25, 2025 · Class II · Z-0936-2026: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

## Indications for use
Machine: The 5008 X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration. The 5008X Machine is equipped with a bibag system, but it may also be used with liquid bicarbonate using the connector included with the machine. The bibag System is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended to be used as one component in the preparation of dialysate according to a physician’s prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module. The 5008X Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System. The optional CLiC system is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting. DIASAFEPIlusUS Filter: The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, non- pyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system). The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be <200 CFU/mL and <2 EU/mL, respectively. The DIASAFE®plusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFE®plusUS. 5008X Tubing Set: The blood tubing sets are intended to be used only with the Fresenius Medical Care 5008X Hemodialysis Device, which is indicated for intermittent hemodialysis treatment for patients with acute kidney injury or chronic kidney disease in a healthcare facility. Therapy options include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration. The HDF blood tubing sets are indicated for use with a prescribed dialyzer. For use with a compatible dialyzer, as per the labeling. Additional Indications for Use for the blood tubing set equipped with Twister AFRC The Fresenius Twister Access Flow Reversing Connector (AFRC) is indicated for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices in order to obtain an access flow measurement. Additional Indications for Use for the blood tubing set equipped with CLiC The blood tubing set is intended to be used with the Crit-Line Clip Monitor System (CLiC) on the 5008 X Hemodialysis Device. The CLiC is used to non-invasively measure hematocrit, oxygen saturation, and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (1.e., increases or decreases the rate at which tluid 1s removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting. CitraSure Disinfectant: CitraSure is intended for thermal disinfection of the Fresenius Medical Care 5008X Hemodialysis System when delivered and diluted per the 5008X heat disinfection program.

Source page: https://510kreport.com/device/K243505
Methodology: https://510kreport.com/methodology