SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
FDA 510(k) K242269 · Quanta Dialysis Technologies, Ltd.
510(k) numberK242269
Submission
- Device name
- SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
- Applicant
- Quanta Dialysis Technologies, Ltd.
Warwick, GB - Received
- August 1, 2024
- Decision date
- November 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONW – Hemodialysis System For Home Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Other 510(k)s with product code ONW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | Fresenius Medical Care North America | 07/03/2013SE |
| K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)ONW · Special | Fresenius Medical Care North America, Design Cente | 01/17/2013SE |
| K070049 | Fresenius 2008K @Home with Wireless Wetness DetectorONW · Traditional | Fresenius Medical Care North America | 02/03/2011SE |
More from Fresenius Medical Care North America
| 510(k) | Device | Decision |
|---|---|---|
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI · Traditional | 11/10/2022SE |
| 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-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) cleared by the FDA?
SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (K242269) received a 510(k) decision of Substantially Equivalent on November 1, 2024, 92 days after the submission was received.
What is the product code of K242269?
The FDA product code is ONW – Hemodialysis System For Home Use, a Class II (moderate risk) device regulated under 21 CFR 876.5860.