510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SAKClass II

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

21 CFR 880.6316 / General Hospital
FDA source (opens on fda.gov)

SAK is the FDA product code for Software Device To Aid In The Prediction Or Diagnosis Of Sepsis, a class II device type, regulated under 21 CFR 880.6316. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAK
Device name
Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
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.
Regulation
21 CFR 880.6316
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SAK

By decision year
2 clearances under product code SAK with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SAK by decision year
YearClearances
20241
20261

Applicants with the most clearances

Product code SAK
Applicants holding the most 510(k) clearances under product code SAK
ApplicantClearances
Bayesian Health, Inc.1
Prenosis, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code