DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)— 510(k) K243264

Name: FDA 510(k) clearance K243264
Creator: U.S. Food and Drug Administration
Published: 2025-04-25

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K243264 for DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14), Substantially Equivalent on 2025-04-25. Applicant: Sorin Group Italia S.R.L.. Device class: 2.

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-15
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola ( Modena), IT

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.