Devices · Bayesian Health, Inc.

Bayesian Health Sepsis Flagging Device

Bayesian Health, Inc. is listed for Bayesian Health Sepsis Flagging Device (K250680). The FDA list gives April 30, 2026 as the date of the final decision. The lead panel is General Hospital, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SAK as “Software Device To Aid In The Prediction Or Diagnosis Of Sepsis”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250680

Official FDA database record

Date of final decision

April 30, 2026

Company on the FDA list

Bayesian Health, Inc.

Lead panel

General Hospital

Primary product code

SAK

openFDA device name for the code

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Device class

2

Regulation number

880.6316

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary