# K121497: Venofer Pump

- Pathway: 510(k) (Traditional)
- Applicant: Renal Solutions, Inc.
- Decided: Aug 17, 2012 after 88 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921456 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103564: Venofer Pump, Renal Solutions, Inc. (2011) Summary page 1.

## Recalls of this device
- Apr 1, 2013 · Class II · Z-2082-2013: Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) deli

## Indications for use
The Venofer Pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

Source page: https://510kreport.com/device/K121497
Methodology: https://510kreport.com/methodology