# K980659: Dryalysate Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Renal Technologies, Inc.
- Decided: Jun 11, 1998 after 111 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 K864265 (1987). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911459: Granulyte Powder Dialysate Concentrate and Mixing, Fresenius USA, Inc. (1991) Summary page 2.
- K922005: Granulyte Dialysate Concentrate, Fresenius USA, Inc. (1994) Summary page 2.
- K864265: Hemodialysis Bath Concentrate Solutions for Hemodi, Dial Medical of Florida, Inc. (1987) Summary page 2.
- K901471: GC-1000 Through GC-3005 Acid Concentrate, Granite Chemical Co., Inc. (1990) Summary page 2.

## Most influential descendants
- K160847: Rockwell Medical CitraPure Acid Concetrate (2016), 5 descendants of its own
- K171750: Citric Complete Dry Citric Acid (45X) (2018), 2 descendants of its own
- K223431: Citric Complete Liquid Citric Acid Concentrate (2023), 1 descendant of its own
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own
- K192209: Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate (2020), 0 descendants of its own

## Indications for use
DRYalysate™ Concentrate is indicated for use for patients being treated by hemodialysis. The patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.

Source page: https://510kreport.com/device/K980659
Methodology: https://510kreport.com/methodology