# K060333: Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System

- Pathway: 510(k) (Traditional)
- Applicant: Dialysis Services, Inc.
- Decided: Sep 8, 2006 after 211 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: 2 generations back to K003560 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031502: Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System, Usfilter (2004) Summary page 1.

## Indications for use
The bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments.

Source page: https://510kreport.com/device/K060333
Methodology: https://510kreport.com/methodology