Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is an FDA 510(k)-cleared medical device (K251636) manufactured by Baxter Healthcare Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2025. Regulation: 8.