Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bayesian Health Sepsis Flagging Device

K-Number: K250680 · 2026-04-30

ApplicantBayesian Health, Inc.
Decision Date2026-04-30
Product CodeSAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bayesian Health Sepsis Flagging Device is a medical device manufactured by Bayesian Health, Inc.. It received FDA 510(k) clearance on 2026-04-30 under approval number K250680. The device is classified under product code SAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bayesian Health Sepsis Flagging Device?

Bayesian Health Sepsis Flagging Device is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Bayesian Health, Inc.. The 510(k) number is K250680.

When was Bayesian Health Sepsis Flagging Device approved by the FDA?

Bayesian Health Sepsis Flagging Device received FDA 510(k) clearance on 2026-04-30, under approval number K250680.

What company makes Bayesian Health Sepsis Flagging Device?

Bayesian Health Sepsis Flagging Device is manufactured by Bayesian Health, Inc..

What is the FDA product code for Bayesian Health Sepsis Flagging Device?

The FDA product code for Bayesian Health Sepsis Flagging Device is SAK.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑