SAK

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Product code

SAK

Device name

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Device class

Class 2

21 CFR

21 CFR 880.6316

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-30.

1 summaries are archived here for direct download.