2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
FDA 510(k) K150708 · Fresenius Medical Care Renal Therapies Group, LLC
510(k) numberK150708
Submission
- Device name
- 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
Waltham, MA, US - Received
- March 19, 2015
- Decision date
- December 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | 05/15/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | 02/10/2026SE |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO · Traditional | 01/29/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | 12/18/2025SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | 11/24/2025SE |
| K250471 | AquaC UNO HFIP · Traditional | 11/14/2025SE |
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | 10/09/2025SE |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…KPO · Traditional | 09/09/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | 06/13/2025SE |
Questions and answers
When was 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine cleared by the FDA?
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (K150708) received a 510(k) decision of Substantially Equivalent on December 10, 2015, 266 days after the submission was received.
What is the product code of K150708?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.