SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
FDA 510(k) K222067 · Quanta Dialysis Technologies, Ltd.
510(k) numberK222067
Submission
- Device name
- SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
- Applicant
- Quanta Dialysis Technologies, Ltd.
Alcester, GB - Received
- July 13, 2022
- Decision date
- November 10, 2022
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…ONW · Traditional | 11/01/2024SE |
| K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetKDI · Traditional | 08/12/2021SE |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI · Traditional | 12/23/2020SE |
Questions and answers
When was SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set cleared by the FDA?
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K222067) received a 510(k) decision of Substantially Equivalent on November 10, 2022, 120 days after the submission was received.
What is the product code of K222067?
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.