AI devices with FDA product code SAK — Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Product code SAK (“Software Device To Aid In The Prediction Or Diagnosis Of Sepsis” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the General Hospital panel (2). The most recent decision was Bayesian Health Sepsis Flagging Device on April 30, 2026.