FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000— 510(k) K220721

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K220721 for FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000, Substantially Equivalent on 2023-05-11. Applicant: 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: 2022-03-14
Decision date: 2023-05-11
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.