| 2026-06-22 | K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | Anesthesiology |
| 2026-06-02 | K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | Anesthesiology |
| 2026-05-01 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | Anesthesiology |
| 2026-04-27 | K252628 | CASSIE | Wesper, Inc. | Anesthesiology |
| 2025-12-10 | K252497 | SANSA HSAT | Huxley Medical | Anesthesiology |
| 2025-12-05 | K251657 | Personalized Therapy Comfort Settings (PTCS) | ResMed Corp | Anesthesiology |
| 2025-10-29 | K250882 | SANSA HSAT | Huxley Medical | Anesthesiology |
| 2025-08-15 | K250818 | Nerveblox | Smart Alfa Teknoloji San. Ve Tic. A.S. | Anesthesiology |
| 2025-04-07 | K243567 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | Anesthesiology |
| 2025-02-28 | K242798 | Airmod | Heroic Faith International Ltd. | Anesthesiology |
| 2025-02-03 | K243268 | TipTraQ (TTQ001) | PranaQ Pte. Ltd. | Anesthesiology |
| 2025-01-28 | K244027 | SANSA HSAT | Huxley Medical | Anesthesiology |
| 2024-09-13 | K240929 | Sleep Apnea Notification Feature (SANF) | Apple Inc. | Anesthesiology |
| 2024-07-15 | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | Anesthesiology |
| 2024-07-02 | K240555 | Tyto Insights for Crackles Detection | Tyto Care Ltd. | Anesthesiology |
| 2024-02-09 | K231355 | Aurora | EnsoData | Anesthesiology |
| 2024-02-06 | DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd | Anesthesiology |
| 2023-12-13 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care Ltd. | Anesthesiology |
| 2023-10-06 | K232787 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | Anesthesiology |
| 2023-03-31 | DEN200011 | Masimo SafetyNet | Masimo Corporation | Anesthesiology |
| 2023-02-23 | K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | Anesthesiology |
| 2023-02-17 | DEN210022 | PMD-200 | Medasense Biometrics Ltd. | Anesthesiology |
| 2022-10-18 | DEN220024 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | Anesthesiology |
| 2022-10-05 | K221892 | VISIONAIR | PacificMD Biotech Llc | Anesthesiology |
| 2020-01-02 | K183089 | Air Next | NuvoAir AB | Anesthesiology |
| 2019-02-04 | K181916 | d-Nav System | Hygieia, Inc | Anesthesiology |
| 2017-05-05 | K163665 | MATRx plus | Zephyr Sleep Technologies | Anesthesiology |
| 2015-11-05 | K150102 | SnoreSounds | APPIAN MEDICAL, INC. | Anesthesiology |
| 2015-04-24 | K142918 | EndoTool SubQ | MONARCH MEDICAL TECHNOLOGIES | Anesthesiology |
| 1997-03-11 | K955841 | SLEEP SYSTEM FOR CLINICS & RESEARCH | COMPUMEDICS PTD LTD. | Anesthesiology |