# K120017: Fresenius 2008 Hemodiaysis Machine with Bibag System

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Feb 2, 2012 after 30 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921456 (1994). 8 ancestors in all.
14 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)
- K101715: Fresenius 2008T Hemodialysis Machine Model 190573, Fresenius Medical Care North America, Design Cente (2010) Summary page 2.

## Most influential descendants
- 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
- K153449: 2008K2 Hemodialysis Machine (2016), 8 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.

## 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/K120017
Methodology: https://510kreport.com/methodology