HMB32— 510(k) K150966

Name: FDA 510(k) clearance K150966
Creator: U.S. Food and Drug Administration
Published: 2015-12-04

Substantially Equivalent

Haemopharm Biofluids S.R.L.

FDA 510(k) clearance K150966 for HMB32, Substantially Equivalent on 2015-12-04. Applicant: Haemopharm Biofluids S.R.L.. Device class: 2.

Clearance details

Applicant: Haemopharm Biofluids S.R.L.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2015-04-13
Decision date: 2015-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tovo Di S. Agata, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPO

view all

K260799 — Nipro Dry Acid Concentrate Mixer2026-08-19
K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)2026-01-29
K252180 — Bicarby Dialysate RFP-404 (RFP-404-W) +7 more2025-09-09
K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 more2025-04-04
K240920 — HemoCare Bicarbonate Concentrate Set (BCS)2024-07-12

More clearances from Haemopharm Biofluids S.R.L.

view all

K212052 — HMB32 Dialysis Solution2021-07-23

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.