# K222952: 2008T BlueStar Hemodailysis Machine

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Oct 27, 2022 after 30 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: 11 generations back to K921456 (1994). 19 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173972: 2008T BlueStar Hemodialysis Machine, Fresenius Medical Care Renal Therapies Group, LLC (2018) Summary page 4.

## Most influential descendants
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own

## Recalls of this device
- Apr 17, 2024 · Class II · Z-1867-2024: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Apr 17, 2024 · Class II · Z-1869-2024: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Apr 17, 2024 · Class II · Z-1870-2024: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Apr 17, 2024 · Class II · Z-1868-2024: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- 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.

## Indications for use
The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing > 20 kg and < 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing < 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid. bibag System (Optional): The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and 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 BlueStar 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/K222952
Methodology: https://510kreport.com/methodology