FDA-cleared AI microbiology devices
The FDA's AI-enabled device list has 7 devices whose lead review panel is Microbiology, 0.4% of all 1,614 listed devices. They come from 7 companies. The first decision was on August 21, 2013 and the most recent on January 22, 2026.
7AI devices
7Companies
2013First decision
2026-01-22Latest decision
Trend: devices per year
20132019202020252026
Top companies
Most common product codes
All 7 devices, newest first
- PhenoMATRIXCopan Wasp Srl · Microbiology
- TriVerityInflammatix, Inc. · Microbiology
- Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. · Microbiology
- APAS Independence with Urine Analysis ModuleClever Culture Systems AG · Microbiology
- FluChip-8G Influenza A+B AssayInDevR, Inc. · Microbiology
- MALDI BIOTYPER CA (MBT-CA) SYSTEMBRUKER DALTONICS, INC · Microbiology
- VITEK MSBIOMERIEUX, INC. · Microbiology
Frequently asked questions
How many FDA-cleared AI microbiology devices are there?
As of the FDA list updated through June 29, 2026, 7 AI-enabled devices have Microbiology as their lead review panel (0.4% of the list).
Which companies have the most AI microbiology devices?
Copan Wasp Srl (1), Inflammatix, Inc. (1), Accelerate Diagnostics, Inc. (1) have the most AI-enabled microbiology devices on the FDA list.
Which year had the most AI microbiology authorizations?
2013 had the most, with 2 devices.
Which FDA pathways are used for AI microbiology devices?
510(k): 6; De Novo: 1.
What was the most recent AI microbiology device on the list?
PhenoMATRIX from Copan Wasp Srl (K251511), with a decision dated January 22, 2026.