K242269 is an FDA 510(k) clearance for the SC+ Hemodialysis Device (SC-14269). This device is classified as a Hemodialysis System For Home Use (Class II - Special Controls, product code ONW).
Submitted by Quanta Dialysis Technologies, Ltd. (Warwick, GB). The FDA issued a Cleared decision on November 1, 2024, 92 days after receiving the submission on August 1, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860. To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients..
| 510(k) Number | K242269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2024 |
| Decision Date | November 01, 2024 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ONW - Hemodialysis System For Home Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |
| Definition | To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients. |