DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Fresenius Medical Care
Product code
Code KPO
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lexington, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KPO

product code KPO
Death
14
Malfunction
775
Other
20
Total
809

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K030497

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030497.

Data sourced from openFDA. This site is unofficial and independent of the FDA.