FDA-cleared AI anesthesiology devices
The FDA's AI-enabled device list has 30 devices whose lead review panel is Anesthesiology, 1.9% of all 1,614 listed devices. They come from 24 companies. The first decision was on March 11, 1997 and the most recent on June 22, 2026.
30AI devices
23Companies
1997First decision
2026-06-22Latest decision
Guides for anesthesiology
Trend: devices per year
1997201520172019202020222023202420252026
Top companies
Most common product codes
All 30 devices, newest first
- RX-1 SleepVivaquant, Inc. Dba Rhythm Express · Anesthesiology
- Tyto Insights for Wheeze Detection (with PCCP)Tyto Care , Ltd. · Anesthesiology
- Capnostream35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · Anesthesiology
- CASSIEWesper, Inc. · Anesthesiology
- SANSA HSATHuxley Medical · Anesthesiology
- Personalized Therapy Comfort Settings (PTCS)ResMed Corp · Anesthesiology
- SANSA HSATHuxley Medical · Anesthesiology
- NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S. · Anesthesiology
- Tyto Insights for Rhonchi DetectionTyto Care , Ltd. · Anesthesiology
- AirmodHeroic Faith International Ltd. · Anesthesiology
- TipTraQ (TTQ001)PranaQ Pte. Ltd. · Anesthesiology
- SANSA HSATHuxley Medical · Anesthesiology
- Sleep Apnea Notification Feature (SANF)Apple Inc. · Anesthesiology
- Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical · Anesthesiology
- Tyto Insights for Crackles DetectionTyto Care Ltd. · Anesthesiology
- AuroraEnsoData · Anesthesiology
- Sleep Apnea FeatureSamsung Electronics Co., Ltd · Anesthesiology
- Tyto Insights for Wheeze DetectionTyto Care Ltd. · Anesthesiology
- ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · Anesthesiology
- Masimo SafetyNetMasimo Corporation · Anesthesiology
- Belun Sleep System BLS-100Belun Technology Company Limited · Anesthesiology
- PMD-200Medasense Biometrics Ltd. · Anesthesiology
- ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · Anesthesiology
- VISIONAIRPacificMD Biotech Llc · Anesthesiology
- Air NextNuvoAir AB · Anesthesiology
- d-Nav SystemHygieia, Inc · Anesthesiology
- MATRx plusZephyr Sleep Technologies · Anesthesiology
- SnoreSoundsAPPIAN MEDICAL, INC. · Anesthesiology
- EndoTool SubQMONARCH MEDICAL TECHNOLOGIES · Anesthesiology
- SLEEP SYSTEM FOR CLINICS & RESEARCHCOMPUMEDICS PTD LTD. · Anesthesiology
Frequently asked questions
How many FDA-cleared AI anesthesiology devices are there?
As of the FDA list updated through June 29, 2026, 30 AI-enabled devices have Anesthesiology as their lead review panel (1.9% of the list).
Which companies have the most AI anesthesiology devices?
Huxley Medical (4), Tyto Care , Ltd. (2), Tyto Care Ltd. (2) have the most AI-enabled anesthesiology devices on the FDA list.
Which year had the most AI anesthesiology authorizations?
2025 had the most, with 8 devices.
Which FDA pathways are used for AI anesthesiology devices?
510(k): 26; De Novo: 4.
What was the most recent AI anesthesiology device on the list?
RX-1 Sleep from Vivaquant, Inc. Dba Rhythm Express (K253148), with a decision dated June 22, 2026.