510(k) · Cleared
ClearedBayesian Health Sepsis Flagging Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayesian Health, Inc. · SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Cleared on Apr 30, 2026 as substantially equivalent to DEN230036 (Prenosis, Inc., 2024) after a 420-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Apr 30, 2026
- Review
- 420 days
- Class
- Class II
- Product code
- SAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230036 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230036 Sepsis ImmunoScorePrenosis, Inc. · 2024
- This deviceK250680 Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230036 | Sepsis ImmunoScore | Prenosis, Inc. | 2024 | — |
| 0 (this device) | K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230036 | Sepsis ImmunoScoreSummary page 5…e SAK Regulation Number 21 CFR 880.6316 Regulatory Class Class II Review Panel Gastroenterology/Urology Submission Type De Novo De Novo Identifier DEN230036 1… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All SAK devicesSAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SAK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SAK
Too few SAK 510(k)s in any year since 2007 to give a median.
Recalls per year · SAK
No recall names SAK since 2007.
Adverse event reports per year · SAK
13in 2025
MAUDE reports naming product code SAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (176 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250680: Bayesian Health Sepsis Flagging Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250680
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026