FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM— 510(k) K120017

Substantially Equivalent

Fresenius Medical Care North America

FDA 510(k) clearance K120017 for FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM, Substantially Equivalent on 2012-02-02. Applicant: Fresenius Medical Care North America.

Clearance details

Applicant: Fresenius Medical Care North America
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2012-01-03
Decision date: 2012-02-02
Decision: Substantially Equivalent
Clearance type: Special
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.