# K041428: Accusol Dialysis Solution

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 27, 2004 after 91 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: 2 generations back to K864265 (1987). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013448: Prismasate, Gambro Renal Products (2002) Summary page 1.
- K910270: Premixed Dialysate for Hemodiafiltration, Baxter Healthcare Corp (1991) Summary page 1.
- K895199: Biasol Liquid Concentrates, Add'l Acid Concentrate, Baxter Healthcare Corp (1989) Summary page 1.

## Most influential descendants
- K150966: HMB32 (2015), 1 descendant of its own
- K212052: HMB32 Dialysis Solution (2021), 0 descendants of its own

## Indications for use
Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy

Source page: https://510kreport.com/device/K041428
Methodology: https://510kreport.com/methodology