# K133299: Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care, North America - Renal Ther
- Decided: Jul 7, 2014 after 255 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: 8 generations back to K921456 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System, Fresenius Medical Care North America (2012) Summary page 2.
- K124035: 2008K@Home Hemodialysis Machine, Fresenius Medical Care North America (2013) Summary page 2.
- K994267: Fresenius 2008K, Fresenius Medical Care (2000) Summary page 2.

## Indications for use
The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.

Source page: https://510kreport.com/device/K133299
Methodology: https://510kreport.com/methodology