About This 510(k) Submission
K243264 is an FDA 510(k) clearance for the DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14), a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Sorin Group Italia S.R.L. (Mirandola ( Modena), IT). The FDA issued a Cleared decision on April 25, 2025, 192 days after receiving the submission on October 15, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.