510(k) K250680
K250680 is an FDA 510(k) premarket notification submitted by Bayesian Health, Inc. for the device "Bayesian Health Sepsis Flagging Device". The FDA issued a decision of Substantially Equivalent on Apr 30, 2026. The device falls under product code SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis), a Class II device regulated under 21 CFR 880.6316.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 30, 2026
- Date Received
- Mar 6, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- Device Class
- Class II
- Regulation Number
- 880.6316
- Review Panel
- GU
- Submission Type
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.