# K153449: 2008K2 Hemodialysis Machine

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Apr 26, 2016 after 148 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921456 (1994). 17 ancestors in all.
8 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 4.
- K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine, Fresenius Medical Care Renal Therapies Group, LLC (2015). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- 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
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own

## Recalls of this device
- Jan 29, 2020 · Class II · Z-1529-2020: The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
- Dec 14, 2017 · Class II · Z-1278-2018: When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the dis

## Indications for use
The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis 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 2008K2 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.

Source page: https://510kreport.com/device/K153449
Methodology: https://510kreport.com/methodology