FDA-cleared AI general hospital devices
The FDA's AI-enabled device list has 6 devices whose lead review panel is General Hospital, 0.4% of all 1,614 listed devices. They come from 5 companies. The first decision was on August 5, 2016 and the most recent on April 30, 2026.
6AI devices
5Companies
2016First decision
2026-04-30Latest decision
Trend: devices per year
2016201920242026
Top companies
Most common product codes
All 6 devices, newest first
- Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc. · General Hospital
- SurgiCount+ SystemStryker Instruments · General Hospital
- Sepsis ImmunoScorePrenosis, Inc. · General Hospital
- SurgiCount+ SystemStryker Instruments · General Hospital
- WellDoc BlueStarWellDoc, Inc. · General Hospital
- Triton SystemGAUSS SURGICAL INC. · General Hospital
Frequently asked questions
How many FDA-cleared AI general hospital devices are there?
As of the FDA list updated through June 29, 2026, 6 AI-enabled devices have General Hospital as their lead review panel (0.4% of the list).
Which companies have the most AI general hospital devices?
Stryker Instruments (2), Bayesian Health, Inc. (1), Prenosis, Inc. (1) have the most AI-enabled general hospital devices on the FDA list.
Which year had the most AI general hospital authorizations?
2024 had the most, with 2 devices.
Which FDA pathways are used for AI general hospital devices?
510(k): 5; De Novo: 1.
What was the most recent AI general hospital device on the list?
Bayesian Health Sepsis Flagging Device from Bayesian Health, Inc. (K250680), with a decision dated April 30, 2026.