# K093902: Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: May 27, 2010 after 156 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: 3 generations back to K921456 (1994). 3 ancestors in all.
36 later devices descend from it; 2 cite it directly.
4 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080964: Fresenius Model 2008T Hemodialysis Machine, Fresenius Medical Care North America (2009) Summary page 2.

## Most influential descendants
- 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
- K101715: Fresenius 2008T Hemodialysis Machine Model 190573 (2010), 15 descendants of its own

## Recalls of this device
- Nov 12, 2013 · Class II · Z-0629-2014: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
- 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 is indicated for acute and chronic dialysis therapy

Source page: https://510kreport.com/device/K093902
Methodology: https://510kreport.com/methodology