FDA 510(k) – Rika Plasma Donation System (BK231035)

Original Request: Records related to the 510(k) clearance for the Rika Plasma Donation System (“Rika System”) (BK231035), submitted by Terumo BCT, Inc., and cleared on March 7, 2024, including the original 510(k) submission, amendments, and supplements; all related correspondence with Terumo; internal FDA communications and decisions regarding the data used to support the nomogram in the Rika System; copies of any clinical studies or clinical study data used to support the 510(k) clearance for the Rika System; and any descriptions of the individualized nomogram that the Rika System uses.