# K150966: HMB32

- Pathway: 510(k) (Traditional)
- Applicant: Haemopharm Biofluids S.R.L.
- Decided: Dec 4, 2015 after 235 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: 3 generations back to K864265 (1987). 7 ancestors in all.
1 later device descends 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)
- K041428: Accusol Dialysis Solution, Baxter Healthcare Corp (2004) Summary page 4.

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

## Indications for use
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

Source page: https://510kreport.com/device/K150966
Methodology: https://510kreport.com/methodology