DeviceClearance

2008T HD SYS. CDX BLUESTAR (191124) +3 more— 510(k) K243237

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K243237 for 2008T HD SYS. CDX BLUESTAR (191124) +3 more, Substantially Equivalent on 2025-06-13. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.

Clearance details

Device name as filed
2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
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, MD, 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 K243237

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 K243237.

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