# K031502: Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System

- Pathway: 510(k) (Traditional)
- Applicant: Usfilter
- Decided: Aug 27, 2004 after 472 days
- Product code: FIN (Tank, Holding, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003560 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003560: Mar Cor Services Bicarb System, Mar Cor Services, Inc. (2001) Summary page 1.

## Most influential descendants
- K060333: Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System (2006), 0 descendants of its own

## Indications for use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.

Source page: https://510kreport.com/device/K031502
Methodology: https://510kreport.com/methodology