# K112427: Bicarb Mixing and Distribution System

- Pathway: 510(k) (Special)
- Applicant: Isopure, Corp.
- Decided: Jan 26, 2012 after 156 days
- Product code: FIN (Tank, Holding, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920186 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993272: Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System, Pure Water, Inc. (2000) Summary page 1.

## Recalls of this device
- Apr 28, 2022 · Class II · Z-1360-2022: Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is ale
- Apr 19, 2019 · Class II · Z-0822-2020: There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of 

## Indications for use
The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Source page: https://510kreport.com/device/K112427
Methodology: https://510kreport.com/methodology