SAK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6316
- Medical specialty
- General Hospital
- FDA 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.
- Adverse events (MAUDE)
- 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Bayesian Health Sepsis Flagging Device (K250680) | Bayesian Health, Inc. | 2026-04-30 |
| Sepsis ImmunoScore (DEN230036) | Prenosis, Inc. | 2024-04-02 |
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