K153449

Substantially Equivalent

2008K2 Hemodialysis Machine

Applicant: Fresenius Medical Care Renal Therapies Group, LLC
Product code: KDI
Advisory panel: Gastroenterology, Urology
Date received: 2015-11-30
Decision date: 2016-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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.