2 devices · 2 companies · 2024 to 2026
Product code SAK: Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
2 devices under product code SAK, 2024 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Software Device To Aid In The Prediction Or Diagnosis Of Sepsis. 21 CFR 880.6316, Class II. 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. MAUDE held 35 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Bayesian Health Sepsis Flagging DeviceK250680 · 510(k) | Bayesian Health, Inc. | General Hospital | database entry | |
| Sepsis ImmunoScoreDEN230036 · De Novo | Prenosis, Inc. | General Hospital | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.