# K921456: Fresenius 3008/FDS-08 Dialysate Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius USA, Inc.
- Decided: Apr 20, 1994 after 754 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 2 cite it directly.
4 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994267: Fresenius 2008K (2000), 56 descendants of its own
- 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

## Recalls of this device
- 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-2227-2010: 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.
- Nov 20, 2009 · Not classified · Z-2224-2010: 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.

Source page: https://510kreport.com/device/K921456
Methodology: https://510kreport.com/methodology