De Novo · Granted
GrantedSepsis ImmunoScore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prenosis, Inc. · SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Granted on Apr 2, 2024 as a new device type through De Novo after a 333-day review. 1 later device descends from it.
- Decided
- Apr 2, 2024
- Review
- 333 days
- Class
- Class II
- Product code
- SAK
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN230036 Sepsis ImmunoScorePrenosis, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250680 Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K250680Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230036 | Sepsis ImmunoScore | Prenosis, Inc. | 2024 | — |
| +1 | K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo 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.
Top candidate predicates for a new SAK device
- #1 K250680 Bayesian Health Sepsis Flagging Devicescore 11.3 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250680 | Bayesian Health Sepsis Flagging Device | 2026 | 0 |
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?
- Of its descendants, K250680 (Bayesian Health, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2024, 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 Sepsis ImmunoScore is an Artificial Intelligence/Machine Learning (AI/ML)-Based Software that identifies patients at risk for having or developing sepsis. The Sepsis ImmunoScore uses up to 22 predetermined inputs from the patient’s electronic health record to generate a risk score and to assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis. The Sepsis ImmunoScore is intended to be used in…
Read the full statement (152 words)
The Sepsis ImmunoScore is an Artificial Intelligence/Machine Learning (AI/ML)-Based Software that identifies patients at risk for having or developing sepsis.
The Sepsis ImmunoScore uses up to 22 predetermined inputs from the patient’s electronic health record to generate a risk score and to assign the patient to one of four discrete risk stratification categories, based on the increasing risk of sepsis.
The Sepsis ImmunoScore is intended to be used in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for presence of or progression to sepsis within 24 hours of patient assessment. It is intended to be used for patients admitted to the Emergency Department or hospital for whom sepsis is suspected, and a blood culture was ordered as part of the evaluation for sepsis. It should not be used as the sole basis to determine the presence of sepsis or risk of developing sepsis within 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230036 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230036: Sepsis ImmunoScore.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026