5008X Hemodialysis System— 510(k) K231534

Substantially Equivalent

Fresenius Medical Care

FDA 510(k) clearance K231534 for 5008X Hemodialysis System, Substantially Equivalent on 2024-02-02. Applicant: Fresenius Medical Care.

Clearance details

Applicant: Fresenius Medical Care
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-30
Decision date: 2024-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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.