510(k) K131908— 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

Clearance details

Applicant: Fresenius Medical Care Renal Therapies Group, LLC
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-26
Decision date: 2013-10-11
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.