# K983618: Dri-Sate Mixer for Preparation of Acidified Dialysate Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Rockwell Medical Technologies, Inc.
- Decided: Aug 5, 1999 after 294 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- 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 K944493 (1996). 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)
- K944493: Reverse Osmosis System, G.E.M. Water Systems (1996) Summary page 3.

## Most influential descendants
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own

## Indications for use
The Rockwell Medical Technologies’ Dri-Sate ™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors.

Source page: https://510kreport.com/device/K983618
Methodology: https://510kreport.com/methodology