# K111639: Fresenius 2008T Hemodialysis Machine

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care
- Decided: Oct 21, 2011 after 130 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921456 (1994). 4 ancestors in all.
19 later devices descend from it; 1 cites it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093902: Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573, Fresenius Medical Care North America (2010) Summary page 1.

## Most influential descendants
- 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
- K150880: Tablo Console with Wireless Capability (2015), 11 descendants of its own
- K160881: Tablo Console (2016), 10 descendants of its own

## Recalls of this device
- 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
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

Source page: https://510kreport.com/device/K111639
Methodology: https://510kreport.com/methodology