FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES— 510(k) K030497

Substantially Equivalent

Fresenius Medical Care

FDA 510(k) clearance K030497 for FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES, Substantially Equivalent on 2003-05-20. Applicant: Fresenius Medical Care.

Clearance details

Applicant: Fresenius Medical Care
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-19
Decision date: 2003-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.