Bayesian Health Sepsis Flagging Device is an AI-enabled medical device from Bayesian Health, Inc. that the U.S. FDA cleared through 510(k) K250680 on April 30, 2026. Its lead review panel is General Hospital and its primary product code is SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis).
See also all FDA AI clearances in 2026.
Key facts
| Submission number | K250680 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Bayesian Health, Inc. |
| Lead review panel | General Hospital |
| Primary product code | SAK — Software Device To Aid In The Prediction Or Diagnosis Of Sepsis |
| Applicant (openFDA) | Bayesian Health, Inc. |
| Applicant location | New York, NY, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 880.6316 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Bayesian Health Sepsis Flagging Device went through this pathway (K250680).
openFDA lists it as a Class 2 device under 21 CFR 880.6316. Class II devices are moderate risk and are subject to general and special controls.
Product code SAK covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Bayesian Health, Inc. has 1 AI-enabled device on the list, and the General Hospital panel accounts for 6 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.