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Bayesian Health Sepsis Flagging Device
Bayesian Health, Inc.
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.
FDA Submission Metadata
- Submission number
- K250680
- Decision date
- April 2026
- FDA panel
- General Hospital
- Product code
- SAK
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
K250680
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.