General Hospital · 510(k) · 2026
Bayesian Health Sepsis Flagging Device
Bayesian Health, Inc.. Cleared by FDA on 30 April 2026 under submission K250680, product code SAK (software device to aid in the prediction or diagnosis of sepsis). What FDA's record says, in FDA's words.
Device record · K250680
- Device. Bayesian Health Sepsis Flagging DeviceDEVICE
- Company. Bayesian Health, Inc.COMPANY
- Decision. 30 April 2026, 510(k), substantially equivalent (traditional review); received 6 March 2025DECISION
- Panel. General HospitalPANEL
- Product code. SAK, Software Device To Aid In The Prediction Or Diagnosis Of SepsisCODE
- Regulation. 21 CFR 880.6316, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 35 reports filed against devices carrying product code SAK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
23 September 2026 · Malfunction · Sepsis · Cerner Corporation · report 1931259-2026-00018
On August 25, 2026, Cerner became aware of a temporary third-party network interruption affecting the Sepsis service. During the interruption, processing of Sepsis outcomes and delivery of notifications were delayed. The issue was resolved, processing resumed, and all delayed items were processed. Customers were notified during the event and instructed to manually monitor patients for sepsis while notifications were delayed. No patient adverse events were reported in connection with this […]
7 August 2026 · Malfunction · Sepsis · Cerner Corporation · report 1931259-2026-00016
7 August 2026 · Malfunction · Sepsis · Cerner Corporation · report 1931259-2026-00015
29 June 2026 · Malfunction · SEPSIS · CERNER CORPORATION · report 1931259-2026-00014
ON (B)(6) 2026, A SINGLE CUSTOMER EXPERIENCED DELAYED SEPSIS PROCESSING DUE TO A PROCESSING STALL, RESULTING IN A BACKLOG AND DELAYED PROCESSING FOR APPROXIMATELY 2 HOURS AND 26 MINUTES. FOLLOWING REMOVAL OF THE RECORD ASSOCIATED WITH THE PROCESSING STALL, NORMAL PROCESSING RESUMED AND THE BACKLOG CLEARED. NO PATIENT HARM OR ADVERSE PATIENT OUTCOMES HAVE BEEN REPORTED.
24 June 2026 · Malfunction · SEPSIS · CERNER CORPORATION · report 1931259-2026-00012
ON (B)(6) 2026, A SINGLE CUSTOMER EXPERIENCED A SEPSIS PROCESSING DELAY FOLLOWING A MILLENNIUM 2026.01 UPTIME UPGRADE. INCREASED INCOMING DATA VOLUME RESULTED IN A PROCESSING BACKLOG, CAUSING A MAXIMUM DELAY OF APPROXIMATELY 3 HOURS AND 29 MINUTES. RECOVERY ACTIONS WERE IMPLEMENTED TO RESTORE NORMAL PROCESSING, AND ALL QUEUED DATA WAS SUCCESSFULLY PROCESSED AFTER INGESTION STABILIZED. THE CUSTOMER WAS NOTIFIED OF THE ISSUE. NO PATIENT HARM OR ADVERSE PATIENT OUTCOMES HAVE BEEN REPORTED.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SAK, in General Hospital, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.