Bayesian Health Sepsis Flagging Device— 510(k) K250680

Name: FDA 510(k) clearance K250680
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Substantially Equivalent

Bayesian Health, Inc.

FDA 510(k) clearance K250680 for Bayesian Health Sepsis Flagging Device, Substantially Equivalent on 2026-04-30. Applicant: Bayesian Health, Inc.. Device class: 2.

Clearance details

Applicant: Bayesian Health, Inc.
Product code: Code SAK
Device class: Class 2
Regulation: 21 CFR 880.6316
Advisory panel: General Hospital
Date received: 2025-03-06
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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