# K101715: Fresenius 2008T Hemodialysis Machine Model 190573

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America, Design Cente
- Decided: Dec 21, 2010 after 186 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). 7 ancestors in all.
15 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)
- K013724: Bicart, Gambro Renal Products (2002) Summary page 1.
- K873155: Gambro Bicart System, Gambro, Inc. (1987) Summary page 1.
- K093902: Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573, Fresenius Medical Care North America (2010) Summary page 1.

## Most influential descendants
- K120017: Fresenius 2008 Hemodiaysis Machine with Bibag System (2012), 14 descendants of its own
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System (2012), 13 descendants of its own
- K124035: 2008K@Home Hemodialysis Machine (2013), 11 descendants of its own
- K131908: 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) (2013), 10 descendants of its own
- K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (2015), 9 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
The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is 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.

Source page: https://510kreport.com/device/K101715
Methodology: https://510kreport.com/methodology