510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250680Substantially Equivalent

Bayesian Health Sepsis Flagging Device

Bayesian Health, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250680 is the FDA 510(k) clearance record for Bayesian Health Sepsis Flagging Device, a class II device, cleared for Bayesian Health, Inc. on under FDA product code SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis). FDA's definition for product code SAK 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...". FDA records list one 510(k) clearance for Bayesian Health, Inc. As of , FDA records show no recalls naming K250680.

Clearance record

Decision date
Received
(420 days to decision)
Product code
SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Regulation
21 CFR 880.6316
Device class
Class II
Review panel
General Hospital
Applicant
Bayesian Health, Inc. 2 River Ter., New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAK

Trailing 12 months
1 clearance under product code SAK in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260