# K023011: Osmonics Solution Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Osmonics Medical Systems
- Decided: Jun 26, 2003 after 290 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 K970674 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970674: G.E.M. Water Systems, International, G.E.M. Water Systems (1997) Summary page 2.

## Indications for use
The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.

Source page: https://510kreport.com/device/K023011
Methodology: https://510kreport.com/methodology