AI Device Tracker / Anesthesiology
FDA-authorised AI devices in anesthesiology
30 AI-enabled devices with anesthesiology as the lead FDA review panel, newest first. First in this list: 1997; most recent: 2026-06-22.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-06-22 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | K253148 · 510(k) |
| 2026-06-02 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | K252844 · 510(k) |
| 2026-05-01 | Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | K253030 · 510(k) |
| 2026-04-27 | CASSIE | Wesper, Inc. | K252628 · 510(k) |
| 2025-12-10 | SANSA HSAT | Huxley Medical | K252497 · 510(k) |
| 2025-12-05 | Personalized Therapy Comfort Settings (PTCS) | ResMed Corp | K251657 · 510(k) |
| 2025-10-29 | SANSA HSAT | Huxley Medical | K250882 · 510(k) |
| 2025-08-15 | Nerveblox | Smart Alfa Teknoloji San. Ve Tic. A.S. | K250818 · 510(k) |
| 2025-04-07 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | K243567 · 510(k) |
| 2025-02-28 | Airmod | Heroic Faith International Ltd. | K242798 · 510(k) |
| 2025-02-03 | TipTraQ (TTQ001) | PranaQ Pte. Ltd. | K243268 · 510(k) |
| 2025-01-28 | SANSA HSAT | Huxley Medical | K244027 · 510(k) |
| 2024-09-13 | Sleep Apnea Notification Feature (SANF) | Apple Inc. | K240929 · 510(k) |
| 2024-07-15 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | K240285 · 510(k) |
| 2024-07-02 | Tyto Insights for Crackles Detection | Tyto Care Ltd. | K240555 · 510(k) |
| 2024-02-09 | Aurora | EnsoData | K231355 · 510(k) |
| 2024-02-06 | Sleep Apnea Feature | Samsung Electronics Co., Ltd | DEN230041 · De Novo |
| 2023-12-13 | Tyto Insights for Wheeze Detection | Tyto Care Ltd. | K232237 · 510(k) |
| 2023-10-06 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | K232787 · 510(k) |
| 2023-03-31 | Masimo SafetyNet | Masimo Corporation | DEN200011 · De Novo |
| 2023-02-23 | Belun Sleep System BLS-100 | Belun Technology Company Limited | K222579 · 510(k) |
| 2023-02-17 | PMD-200 | Medasense Biometrics Ltd. | DEN210022 · De Novo |
| 2022-10-18 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | DEN220024 · De Novo |
| 2022-10-05 | VISIONAIR | PacificMD Biotech Llc | K221892 · 510(k) |
| 2020-01-02 | Air Next | NuvoAir AB | K183089 · 510(k) |
| 2019-02-04 | d-Nav System | Hygieia, Inc | K181916 · 510(k) |
| 2017-05-05 | MATRx plus | Zephyr Sleep Technologies | K163665 · 510(k) |
| 2015-11-05 | SnoreSounds | APPIAN MEDICAL, INC. | K150102 · 510(k) |
| 2015-04-24 | EndoTool SubQ | MONARCH MEDICAL TECHNOLOGIES | K142918 · 510(k) |
| 1997-03-11 | SLEEP SYSTEM FOR CLINICS & RESEARCH | COMPUMEDICS PTD LTD. | K955841 · 510(k) |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.