About This 510(k) Submission
K242269 is an FDA 510(k) clearance for the SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651), 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 review panel. Regulated under 21 CFR 876.5860.