Bayesian Health Sepsis Flagging Device— 510(k) K250680
Substantially EquivalentBayesian Health, Inc.
FDA 510(k) clearance K250680 for Bayesian Health Sepsis Flagging Device, Substantially Equivalent on 2026-04-30. Applicant: Bayesian Health, Inc.. Device class: 2.
Summary
The Bayesian Health Sepsis Flagging Device comes from Bayesian Health, Inc. and is filed under product code SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 880.6316. The record lists General Hospital as the classification panel, but the Gastroenterology and Urology review panel handled this Traditional 510(k).
Bayesian Health filed from New York, New York. Review took 420 calendar days (March 6, 2025 to April 30, 2026).
Clearance details
- Applicant
- Bayesian Health, Inc.
- Product code
- Product code SAK
- Device class
- Class 2
- Regulation
- 21 CFR 880.6316
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code SAK
view allData sourced from openFDA. This site is unofficial and independent of the FDA.