# K080964: Fresenius Model 2008T Hemodialysis Machine

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Jan 14, 2009 after 285 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921456 (1994). 2 ancestors in all.
42 later devices descend from it; 3 cite it directly.
4 of 45 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 2.

## Most influential descendants
- K093902: Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 (2010), 36 descendants of its own
- K111639: Fresenius 2008T Hemodialysis Machine (2011), 19 descendants of its own
- K113427: Fresenius 2008T Hemodialysis Machine (2011), 18 descendants of its own
- K120505: Fresenius 2008T Hemodialysis Machine (2012), 17 descendants of its own
- K140866: Tablo Console (2014), 16 descendants of its own

## Recalls of this device
- Oct 5, 2017 · Class II · Z-0829-2018: While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the ac
- Mar 10, 2016 · Class II · Z-1325-2016: Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
- Feb 20, 2015 · Class II · Z-1550-2015: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
- May 24, 2013 · Class II · Z-1693-2013: Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

## Indications for use
Fresenius2008T is indicated for acute and chronic dialysis therapy.

Source page: https://510kreport.com/device/K080964
Methodology: https://510kreport.com/methodology