# K994267: Fresenius 2008K

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care
- Decided: Mar 16, 2000 after 90 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921456 (1994). 1 ancestor in all.
56 later devices descend from it; 8 cite it directly.
4 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921456: Fresenius 3008/FDS-08 Dialysate Delivery System, Fresenius USA, Inc. (1994) Summary page 1.

## Most influential descendants
- K080964: Fresenius Model 2008T Hemodialysis Machine (2009), 42 descendants of its own
- K093902: Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 (2010), 36 descendants of its own
- 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

## Recalls of this device
- Feb 20, 2015 · Class II · Z-1552-2015: 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.
- Feb 20, 2015 · Class II · Z-1551-2015: 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.
- Dec 16, 2014 · Class II · Z-1015-2015: Unqualified power assemblies shipped to customers.
- Nov 12, 2013 · Class II · Z-0629-2014: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
- Nov 20, 2009 · Not classified · Z-2225-2010: Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.

## Indications for use
The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

Source page: https://510kreport.com/device/K994267
Methodology: https://510kreport.com/methodology