Purema® H Hemoconcentrator (EtO Sterilized)— 510(k) K232171

Name: FDA 510(k) clearance K232171
Creator: U.S. Food and Drug Administration
Published: 2024-02-07

Substantially Equivalent

Tecnoideal America

FDA 510(k) clearance K232171 for Purema® H Hemoconcentrator (EtO Sterilized), Substantially Equivalent on 2024-02-07. Applicant: Tecnoideal America. Device class: 2.

Clearance details

Applicant: Tecnoideal America
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-21
Decision date: 2024-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Derwood, MD, US

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.