ICU Medical Rolls Out New Category of Infusion Pumps

ICU Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for the Plum Solo precision IV pump, a single-channel complement to the dual-channel Plum Duo.

The company also received 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield infusion safety software. The completed the initial launch of the ICU Medical IV Performance Platform.

With these FDA nods, the company introduces its new category of precision IV pumps. These types of pumps are designed to address delivery variability while supporting the need for accurate data in modern patient care.

The new pumps were built on the cassette technology in the Plum 360, Plum Solo, and Plum Duo pumps. The company said they deliver ±3% accuracy in real world conditions, and remove infusion inconsistencies found in traditional pumps.

A unique pumping mechanism allows accurate, precise medication delivery—including whole blood and blood products—for Plum Solo and Duo pumps, no matter where the pump or infusion bag is placed. Full-color touchscreens provide intuitive programming with near-real-time safety feedback.

Simplified drug library and firmware deployment are managed from a central location to ensure devices and consistently updated and pumps are on the most current software version. LifeShield software integration may help with more coordinated care across healthcare systems—the enterprise ecosystem offers a single, harmonized IT platform for ICU Medical’s devices.

“Precision IV pumps represent a critical step forward for infusion therapy,” said Chad Jansen, corporate VP and general manager of ICU Medical Infusion Systems. “With the Plum Solo and Plum Duo, we’re introducing more than just a new device category—we’re setting a new standard. Healthcare teams can now trust not only the delivery of their medications but also the infusion data that supports their decisions, knowing it reflects what patients actually receive.”

“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 went on. “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.”

The Plum Duo infusion pump with LifeShield infusion safety software first received FDA clearance in August 2023.