# K124035: 2008K@Home Hemodialysis Machine

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Jul 3, 2013 after 187 days
- Product code: ONW (Hemodialysis System For Home Use)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921456 (1994). 12 ancestors in all.
11 later devices descend from it; 2 cite it directly.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121421: Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert), Fresenius Medical Care North America, Design Cente (2013). Cleared while this submission was under review Summary page 3.
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System, Fresenius Medical Care North America (2012) Summary page 1.

## Most influential descendants
- 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
- K173972: 2008T BlueStar Hemodialysis Machine (2018), 7 descendants of its own
- K231125: 2008T BlueStar Hemodialysis Machine (2023), 4 descendants of its own
- K222952: 2008T BlueStar Hemodailysis Machine (2022), 3 descendants of its own

## Indications for use
2008K@home Hemodialysis Machine: The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System: The Fresenius Medical Care bibag System is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription. Wireless Wetness Detector (Wet Alert): The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

Source page: https://510kreport.com/device/K124035
Methodology: https://510kreport.com/methodology