# K020231: Diasol-Additives

- Pathway: 510(k) (Traditional)
- Applicant: Diasol, Inc.
- Decided: Oct 21, 2002 after 271 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
Diasol —~Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicatbonatc as Dialyzate solution for acute and chronic hemodiatlysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to moet the patient’s noeds . Dialysatcaddifiveghfiwatamdhxfixmaddifimmforusewimmmafiregmamd dialysis and sllows physicians to customize the dialysate to meet the patient’s needs.

Source page: https://510kreport.com/device/K020231
Methodology: https://510kreport.com/methodology