FDA product code · Gastroenterology and urology

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Name: FDA decisions, review times, recalls and adverse event reports for product code SAK
Creator: 510(k) Report

SAKClass II21 CFR 880.6316510(k) required2 decisions since 20240 recalls

2 FDA decisions since 2024. No recall names this code. The most-cited predicate is DEN230036, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of SAK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SAK

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SAK

Too few SAK 510(k)s in any year since 2007 to give a median.

Recalls per year · SAK

No recall names SAK since 2007.

Adverse event reports per year · SAK

13in 2025

2007high 13 (2025) · low 0 (2007)2025

MAUDE reports naming product code SAK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	3
2025	0	—	13
2026	1	—	—

FIG. 1 — SAK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SAK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Which predicates do SAK devices cite most?

Which SAK devices have the deepest lineage?

What has FDA decided in SAK lately?