FDA Product Code SAK: Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
A Software Device To Aid In The Prediction Or Diagnosis Of Sepsis Uses Advanced Algorithms To Analyze Patient Specific Data To Aid Health Care Providers In The Prediction And/or Diagnosis Of Sepsis. The Device Is Intended For Adjunctive Use And Is Not Intended To Be Used As The Sole Determining Factor In Assessing A Patient's Sepsis Status. The Device May Contain Alarms That Alert The Care Provider Of The Patient's Status. The Device Is Not Intended To Monitor Response To Treatment In Patients Being Treated For Sepsis.
Leading manufacturers include Prenosis, Inc. and Bayesian Health, Inc..
FDA 510(k) Cleared Software Device To Aid In The Prediction Or Diagnosis Of Sepsis Devices (Product Code SAK)
About Product Code SAK - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SAK since 2024, with 1 receiving FDA clearance (average review time: 377 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under SAK have taken an average of 420 days to reach a decision - up from 333 days historically. Manufacturers should account for longer review timelines in current project planning.
SAK devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →