# K131908: 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Oct 11, 2013 after 107 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: 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.
10 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)
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System, Fresenius Medical Care North America (2012) Summary page 3.
- K121599: Crit-Line Clip (Clic), Fresenius Medical Care-North America (2012) Summary page 3.

## 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
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy. The 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. The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.

Source page: https://510kreport.com/device/K131908
Methodology: https://510kreport.com/methodology