# K093964: Venofer Pump

- Pathway: 510(k) (Abbreviated)
- Applicant: Renal Solutions, Inc.
- Decided: Jul 9, 2010 after 197 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: 3 generations back to K921456 (1994). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070739: Allient Sorbent Hemodialysis System, Model# 1500, Renal Solutions, Inc. (2007) Summary page 1.
- K080964: Fresenius Model 2008T Hemodialysis Machine, Fresenius Medical Care North America (2009) Summary page 5.

## Most influential descendants
- K103564: Venofer Pump (2011), 1 descendant of its own
- K121497: Venofer Pump (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K093964
Methodology: https://510kreport.com/methodology