# K020230: Diasol-Bicarb

- Pathway: 510(k) (Traditional)
- Applicant: Diasol, Inc.
- Decided: Apr 23, 2002 after 90 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 K781967 (1978). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792213: Renal Systems Hemodialysis Concentrate, Renal Systems, Inc. (1980) Summary page 1.
- K781967: Hemodialysis Concentrate, Sodiu, Renal Systems, Inc. (1978) Summary page 1.
- K971053: Rockwell Medical Supply,LLC. Bicarbonate Solution Concentrates for Bicarbonate Dialysis, International Medical Products, Inc. (1997) Summary page 1.

## Indications for use
Diasol-BiCarb Solutions are indicated for use in acute and chronic hemodaalysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemnodialysis For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.

Source page: https://510kreport.com/device/K020230
Methodology: https://510kreport.com/methodology