Loading…
Nikkiso Medical America, Inc. was cited for marketing the DBB-06 dialysis device in the United States without required FDA premarket approval (PMA) or investigational device exemption (IDE), and for failing to submit a 510(k) premarket notification when introducing a physiological closed loop controller (PCLC) system—a significant modification that could affect device safety and effectiveness. The company's marketing materials demonstrated intent to commercialize the device with this new PCLC functionality, rendering the device both adulterated and misbranded under federal law.