BD Alaris System is submitted for FDA 510(k) premarket notification
Becton, Dickinson and Company (BD) announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the BD Alaris System, an infusion pump used in acute care hospitals across the United States.
The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris System up to date, implement updated features and address open recall issues, including through a new version of BD Alaris System software that will provide clinical, operational and cybersecurity updates.
The system allows clinicians to deliver medications, fluids and blood products through a single integrated platform that includes large volume pumps, syringe pumps and patient-controlled analgesia (PCA) modules for adult, pediatric and neonatal patients.
