DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

About This 510(k) Submission

K250459 is an FDA 510(k) clearance for the DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Technoflex Sas. (Bidart, FR). The FDA issued a Cleared decision on April 18, 2025, 59 days after receiving the submission on February 18, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.