# K212052: HMB32 Dialysis Solution

- Pathway: 510(k) (Special)
- Applicant: Haemopharm Biofluids S.R.L.
- Decided: Jul 23, 2021 after 23 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: 4 generations back to K864265 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150966: HMB32, Haemopharm Biofluids S.R.L. (2015) Summary page 4.

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

Source page: https://510kreport.com/device/K212052
Methodology: https://510kreport.com/methodology