ICU Medical has announced 510(k) regulatory clearance from the FDA for the Plum Solo precision IV pump, a single-channel complement to the dual-channel Plum Duo. ICU Medical also received 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield infusion safety software, completing the initial launch of the ICU Medical IV Performance Platform. With these FDA clearances, ICU Medical is introducing its new category of precision IV pumps and expanding the ICU Medical IV Performance Platform.
The Plum Solo expands the capabilities of the IV Performance Platform by offering a single-channel pump designed to work alongside the dual-channel Plum Duo.
Together, Plum Solo and Plum Duo provide healthcare systems with the flexibility to choose the right configuration for their infusion needs, optimizing device footprint without compromising performance or safety. Both devices are compatible with whole blood and blood products and deliver consistent ±3% accuracy while eliminating variability from external factors such as infusion setup, temperature, or hospital elevation.
"We are proud of this milestone, but this is just the next step in creating the most comprehensive, precise, and technologically advanced infusion platform," Jansen said. "This milestone delivers on our promised roadmap with 5 products receiving FDA 510(k) clearance in the past 18 months. We look forward to bringing our next-generation Medfusion syringe pump and CADD pain and ambulatory pump products to the LifeShield platform. This is the future of infusion therapy, and we're proud to be leading the way."
