HMB32 Dialysis Solution— 510(k) K212052

Substantially Equivalent

Haemopharm Biofluids S.R.L.

FDA 510(k) clearance K212052 for HMB32 Dialysis Solution, Substantially Equivalent on 2021-07-23. Applicant: Haemopharm Biofluids S.R.L..

Clearance details

Applicant: Haemopharm Biofluids S.R.L.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-30
Decision date: 2021-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Tovo Di S. Agata, IT

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.