510(k) K250680

Device

Bayesian Health Sepsis Flagging Device

Applicant

Bayesian Health, Inc.

510(k) number

K250680

Product code

SAK

Decision

Substantially Equivalent (SESE)

Decision date

2026-04-30

Date received

2025-03-06

Regulation

880.6316

Classification name

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Medical specialty

General Hospital

Review panel

General Hospital

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N