# K982378: Hemsol-Acid Concentrate Liquid Hemogran Acid Concentrate Powder, Nephrosol-Acetate Concentrate Powder, Bicarbosol-Bicare

- Pathway: 510(k) (Traditional)
- Applicant: Solution Technologies
- Decided: Aug 26, 1998 after 49 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K180679: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) (2018), 0 descendants of its own

## Indications for use
This concentrate is formulated to be used with a two stream hemodialysis machine, calibrated to an acetate concentrate dilution ratio of 3.

Source page: https://510kreport.com/device/K982378
Methodology: https://510kreport.com/methodology