2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
FDA 510(k) clearance K150708 · decided 2015-12-10
Clearance details
- K-number
- K150708
- Device name
- 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-03-19
- Decision date
- 2015-12-10
- Days to decision
- 266 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 |
|---|---|---|
| 2008T Hemodialysis SYS, with CDX recall (Z-0028-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T Hemodialysis System without CDX recall (Z-0029-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T Hemodialysis System w/Bibag recall (Z-0030-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T GEN 2 Bibag without CDX recall (Z-0031-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T HD SYS. CDX BLUESTAR recall (Z-0032-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T HD SYS. CDX W/BIBAG BLUESTAR recall (Z-0033-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T HD SYS. W/O CDX BLUESTAR recall (Z-0034-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR recall (Z-0035-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |