# K103564: Venofer Pump

- Pathway: 510(k) (Special)
- Applicant: Renal Solutions, Inc.
- Decided: Feb 10, 2011 after 66 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: 4 generations back to K921456 (1994). 5 ancestors in all.
1 later device descends 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)
- K093964: Venofer Pump, Renal Solutions, Inc. (2010) Summary page 1.

## Most influential descendants
- 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/K103564
Methodology: https://510kreport.com/methodology