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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K250680

510(k) cleared

Bayesian Health Sepsis Flagging Device

Bayesian Health, Inc. · Apr 30, 2026 · K250680

FDA cleared the Bayesian Health Sepsis Flagging Device from Bayesian Health, Inc. on Apr 30, 2026 under K250680, a traditional 510(k). The device falls under product code SAK, Software Device To Aid In The Prediction Or Diagnosis Of Sepsis, regulated at 21 CFR 880.6316 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 6, 2025. The decision came 420 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bayesian Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250680?

K250680 is the FDA 510(k) for Bayesian Health Sepsis Flagging Device, submitted by Bayesian Health, Inc.. FDA's decision date was Apr 30, 2026, under product code SAK (Software Device To Aid In The Prediction Or Diagnosis Of Sepsis).

Who makes the Bayesian Health Sepsis Flagging Device?

Bayesian Health, Inc., based in New York, NY, is the applicant of record for K250680.

How long did the K250680 review take?

FDA received the submission on Mar 6, 2025 and issued its decision on Apr 30, 2026, 420 days later.

← All decisions in April 2026