Bayesian Health Sepsis Flagging Device is an AI-enabled medical device from Bayesian Health, Inc., listed by FDA (510(k), K250680) with a decision date of 2026-04-30. Review panel: General Hospital.
| FDA submission number | K250680 |
|---|---|
| Pathway | 510(k) |
| Company | Bayesian Health, Inc. |
| Review panel (specialty) | General Hospital |
| FDA decision date | 2026-04-30 |
| Decision | Substantially Equivalent |
| Product code | SAK |
| Classification | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis |
| Device class | 2 |
| Regulation number | 880.6316 |
| Review time (calendar days) | 420 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.