DeviceClearance

5008X Hemodialysis System— 510(k) K243505

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K243505 for 5008X Hemodialysis System, Substantially Equivalent on 2025-05-30. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.

Clearance details

Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product code
Code KDI
Device class
Class 2
Regulation
21 CFR 876.5860
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waltham, MA, US
Download summary PDFView on FDA.gov ↗

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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, 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 K243505

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 K243505.

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