Cleared Traditional

K250680 - Bayesian Health Sepsis Flagging Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250680 · Bayesian Health, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
420d
Days
Class 2
Risk

K250680 is an FDA 510(k) clearance for the Bayesian Health Sepsis Flagging Device. Classified as Software Device To Aid In The Prediction Or Diagnosis Of Sepsis (product code SAK), Class II - Special Controls.

Submitted by Bayesian Health, Inc. (New York, US). The FDA issued a Cleared decision on April 30, 2026 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.6316 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Bayesian Health, Inc. devices

Submission Details

510(k) Number K250680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2025
Decision Date April 30, 2026
Days to Decision 420 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 130d · This submission: 420d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6316
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.