# K981043: Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol

- Pathway: 510(k) (Traditional)
- Applicant: Solution Technologies
- Decided: May 26, 1998 after 67 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
1 of 6 devices in its family (counting itself) has 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
- K192017: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (2020), 1 descendant of its own
- K191474: NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) (2020), 1 descendant of its own
- K253462: NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (2026), 0 descendants of its own
- K212620: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (2022), 0 descendants of its own
- K071387: Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB (2007), 0 descendants of its own

## Recalls of this device
- Mar 16, 2012 · Not classified · Z-1612-2012: Sodium content does not meet product requirements

## Indications for use
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHINE 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: [unclear in source]. THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHINE CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.

Source page: https://510kreport.com/device/K981043
Methodology: https://510kreport.com/methodology