# K250680: Bayesian Health Sepsis Flagging Device

- Pathway: 510(k) (Traditional)
- Applicant: Bayesian Health, Inc.
- Decided: Apr 30, 2026 after 420 days
- Product code: SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis)
- Device class: 2
- Regulation: 21 CFR 880.6316
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230036 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230036: Sepsis ImmunoScore, Prenosis, Inc. (2024) Summary page 5.

## Indications for use
The Bayesian Health Sepsis Flagging Device is a continuously monitoring artificial intelligence and machine learning-based software as a medical device intended for use by Health Care Providers (HCPs) in conjunction with clinical assessments and other laboratory data to aid in the early detection and/or risk prediction of sepsis developing within 24 hours. The Bayesian Health Sepsis Flagging Device uses a machine learning algorithm to analyze patient data from the EHR, which includes a combination of patient information, comorbidities, the chief complaint documented at presentation to the emergency department, laboratory measurements and vital signs, and procedures, medications, and consult orders. The Bayesian Health Sepsis Flagging Device outputs a flag ("Sepsis Risk High") that is displayed within the EHR but should not be used as the sole basis to determine the presence of sepsis or risk of developing sepsis within 24 hours. The Bayesian Health Sepsis Flagging Device is intended to be used for adult patients (≥18 years old) upon Emergency Department (ED) presentation or hospital admission throughout the duration of the patient's stay in acute care settings.

Source page: https://510kreport.com/device/K250680
Methodology: https://510kreport.com/methodology