# K990507: Acid Concentrate and Powder, Acetate Concentrate Liquid and Powder, and Bicarbonate Concentrate Liquid and Powder

- Pathway: 510(k) (Traditional)
- Applicant: Althin Biopharm, Inc.
- Decided: May 7, 1999 after 78 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. This concentrate is formulated to be used with a two stream hemodialysis machine calibrated to an acetate concentrate dilution ratio of 1:34.

Source page: https://510kreport.com/device/K990507
Methodology: https://510kreport.com/methodology