FDA product code SAK: Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
SAK is the FDA product code for software device to aid in the prediction or diagnosis of sepsis. It is a Class II device, regulated under 21 CFR 880.6316 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under SAK, 1 in the last five years. The average 510(k) review took 420 days (median 420); 420 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis |
| Device class | Class II |
| Regulation | 21 CFR 880.6316 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for SAK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 420 |
Compare with all 510(k) review times · Search every SAK clearance
Top SAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bayesian Health, Inc. | 1 | 2026-04-30 |
Most recent SAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250680 | Bayesian Health, Inc. | Bayesian Health Sepsis Flagging Device | 2026-04-30 | 420 |
Recalls for SAK devices
openFDA lists no recalls for product code SAK.
Frequently asked questions
What is FDA product code SAK?
SAK is the FDA product code for software device to aid in the prediction or diagnosis of sepsis. It is a Class II device, regulated under 21 CFR 880.6316 and reviewed by the Gastroenterology and Urology panel.
What device class is SAK?
Class II, regulation 21 CFR 880.6316. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAK?
Across 1 cleared submissions the average was 420 days from receipt to decision (median 420).
Which companies have the most SAK clearances?
Bayesian Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAK
- Run a recall and safety report across every SAK manufacturer
- Watch product code SAK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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