DeviceClearance

Product code SAK— General Hospital

Bayesian Health Sepsis Flagging Device

Classification name
Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Device class
Class 2
Regulation
21 CFR 880.6316
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SAK under 21 CFR 880.6316, via openFDA

Market context for product code SAK

FDA has cleared 2 devices under product code SAK between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SAK

Recent clearances under product code SAK

Data sourced from openFDA. This site is unofficial and independent of the FDA.