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 the device name listed in this FDA 510(k) record. The listed applicant is Bayesian Health, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) 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. The listed applicant is Bayesian Health, Inc.. The 510(k) number is K250680.
When did Bayesian Health Sepsis Flagging Device receive FDA 510(k) clearance?
Bayesian Health Sepsis Flagging Device received FDA 510(k) clearance on 2026-04-30, under 510(k) number K250680.
Who is the listed applicant for Bayesian Health Sepsis Flagging Device?
The FDA 510(k) record lists Bayesian Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.