# K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine - Pathway: 510(k) (Traditional) - Applicant: Fresenius Medical Care Renal Therapies Group, LLC - Decided: Dec 10, 2015 after 266 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: 12 (8 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 8 generations back to K921456 (1994). 16 ancestors in all. 9 later devices descend from it; 1 cites it directly. 3 of 26 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K994267: Fresenius 2008K, Fresenius Medical Care (2000) Summary page 5. - K124035: 2008K@Home Hemodialysis Machine, Fresenius Medical Care North America (2013) Summary page 5. - K131908: 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic), Fresenius Medical Care Renal Therapies Group, LLC (2013) Summary page 5. ## Most influential descendants - K153449: 2008K2 Hemodialysis Machine (2016), 8 descendants of its own - K173972: 2008T BlueStar Hemodialysis Machine (2018), 7 descendants of its own - K231125: 2008T BlueStar Hemodialysis Machine (2023), 4 descendants of its own - K222952: 2008T BlueStar Hemodailysis Machine (2022), 3 descendants of its own - K231534: 5008X Hemodialysis System (2024), 2 descendants of its own ## Recalls of this device - Sep 6, 2023 · Class I · Z-0028-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0031-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0035-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0029-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0030-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0032-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0033-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Sep 6, 2023 · Class I · Z-0034-2024: Potential PCBA leaching from tubing of hemodialysis machines. - Dec 21, 2016 · Class II · Z-1026-2017: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate display - Dec 21, 2016 · Class II · Z-1027-2017: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate display - Dec 21, 2016 · Class II · Z-1029-2017: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate display - Dec 21, 2016 · Class II · Z-1028-2017: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate display ## Indications for use 2008K Hemodialysis Machines: The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy. 2008K@home Hemodialysis Machine: The 2008K@home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System (Optional): The bibag System is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription. Wireless Wetness Detector (Wet Alert): The Wireless Wetness Detector is indicated for use with the 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician. 2008T Hemodialysis Machine: The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy. bibag System (Optional): The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription. Crit-Line Clip Monitor (CLiC) (Optional): The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation 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 clinician. 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 complications of dialysis which include nausea, cramping and vomiting Source page: https://510kreport.com/device/K150708 Methodology: https://510kreport.com/methodology