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Barkey GmbH & Co. KG manufactured the Barkey plasmatherm and plasmatherm V devices, which are intended to thaw and warm blood products prior to transfusion, without obtaining required premarket clearance for the newer version. The company introduced the plasmatherm V in August 2021 with significant design modifications—including a change from a single rubber paddle to a larger wire "Smart Motion" paddle designed to reduce thawing time—but failed to submit a new premarket notification (510(k)) to FDA as required under 21 CFR 807.81(a)(3) for devices with substantial modifications. The original plasmatherm device had been cleared in 2011, but the substantially redesigned plasmatherm V was marketed without the necessary premarket approval, constituting a violation of device marketing requirements.