2008T BlueStar Hemodialysis Machine— 510(k) K231125
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K231125 for 2008T BlueStar Hemodialysis Machine, Substantially Equivalent on 2023-12-06. 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
Recent devices under product code KDI
view allMore clearances from Fresenius Medical Care Renal Therapies Group, LLC
view allAdverse 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 K231125
K-number listed on FDA's recall record- Z-1867-2024 — 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Z-1868-2024 — 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Z-1869-2024 — 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Z-1870-2024 — 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231125.
Data sourced from openFDA. This site is unofficial and independent of the FDA.