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Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA product code SAK · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.6316
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-04-30 – 2026-04-30

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.

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