5008X Hemodialysis System
FDA 510(k) clearance K243505 · decided 2025-05-30
Clearance details
- K-number
- K243505
- Device name
- 5008X Hemodialysis System
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-11-12
- Decision date
- 2025-05-30
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptio recall (Z-2702-2026) | Fresenius Medical Care Holdings, Inc. | 2026-07-08 |
| 5008X CAREsystem +CLiC +CDX; recall (Z-0936-2026) | Fresenius Medical Care Holdings, Inc. | 2025-12-17 |