Bayesian Health Sepsis Flagging Device
FDA 510(k) clearance K250680 · decided 2026-04-30
Clearance details
- K-number
- K250680
- Device name
- Bayesian Health Sepsis Flagging Device
- Applicant
- Bayesian Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-06
- Decision date
- 2026-04-30
- Days to decision
- 420 days
- Clearance type
- Traditional
- Product code
- SAK
- Device class
- 2
- Regulation number
- 880.6316
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sepsis ImmunoScore (DEN230036) | Prenosis, Inc. | 2024-04-02 |
Recalls involving this device
No recalls on record reference this clearance.