30 devices · 24 companies · 1997 to 2026
AI-enabled anesthesiology devices on FDA's list
30 devices in the Anesthesiology panel, 1997 to 2026, from 24 companies across 12 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (27 of 30 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Anesthesiology panel
- MNR · Ventilatory Effort Recorder12
- PHZ · Abnormal Breath Sound Device4
- QRG · Ultrasound Guided Nerve Block Assist3
- QZW · Over-The-Counter Device To Assess Risk Of Sleep Apnea2
- NDC · Calculator, Drug Dose2
- CCK · Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1
- BZD · Ventilator, Non-Continuous (Respirator)1
- BZQ · Monitor, Breathing Frequency1
- QVT · Monitor For Opioid Induced Impairment Of Oxygenation1
- QVE · Adjunctive Pain Measurement Device For Anesthesiology1
- BXQ · Rhinoanemometer (Measurement Of Nasal Decongestion)1
- BZG · Spirometer, Diagnostic1
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| RX-1 SleepK253148 · 510(k) | Vivaquant, Inc. Dba Rhythm Express | MNR | database entry | |
| Tyto Insights for Wheeze DetectionK252844 · 510(k) | Tyto Care , Ltd. | PHZ | database entry | |
| Capnostream35 Portable Respiratory MonitorK253030 · 510(k) | Covidien, LLC | CCK | database entry | |
| CASSIEK252628 · 510(k) | Wesper, Inc. | MNR | database entry | |
| SANSA HSATK252497 · 510(k) | Huxley Medical | MNR | database entry | |
| Personalized Therapy Comfort SettingsK251657 · 510(k) | ResMed Corp | BZD | database entry | |
| SANSA HSATK250882 · 510(k) | Huxley Medical | MNR | database entry | |
| NervebloxK250818 · 510(k) | Smart Alfa Teknoloji San. Ve Tic. A.S. | QRG | database entry | |
| Tyto Insights for Rhonchi DetectionK243567 · 510(k) | Tyto Care , Ltd. | PHZ | database entry | |
| AirmodK242798 · 510(k) | Heroic Faith International Ltd. | BZQ | database entry | |
| TipTraQK243268 · 510(k) | PranaQ Pte. Ltd. | MNR | database entry | |
| SANSA HSATK244027 · 510(k) | Huxley Medical | MNR | database entry | |
| Sleep Apnea Notification FeatureK240929 · 510(k) | Apple Inc. | QZW | database entry | |
| Huxley SANSA Home Sleep Apnea TestK240285 · 510(k) | Huxley Medical | MNR | database entry | |
| Tyto Insights for Crackles DetectionK240555 · 510(k) | Tyto Care Ltd. | PHZ | database entry | |
| AuroraK231355 · 510(k) | EnsoData | MNR | database entry | |
| Sleep Apnea FeatureDEN230041 · De Novo | Samsung Electronics Co., Ltd | QZW | database entry | |
| Tyto Insights for Wheeze DetectionK232237 · 510(k) | Tyto Care Ltd. | PHZ | database entry | |
| ScanNav Anatomy Peripheral Nerve BlockK232787 · 510(k) | Intelligent Ultrasound Limited | QRG | database entry | |
| Masimo SafetyNetDEN200011 · De Novo | Masimo Corporation | QVT | database entry | |
| Belun Sleep System BLS-100K222579 · 510(k) | Belun Technology Company Limited | MNR | database entry | |
| PMD-200DEN210022 · De Novo | Medasense Biometrics Ltd. | QVE | database entry | |
| ScanNav Anatomy Peripheral Nerve BlockDEN220024 · De Novo | Intelligent Ultrasound Limited | QRG | database entry | |
| VISIONAIRK221892 · 510(k) | PacificMD Biotech Llc | BXQ | database entry | |
| Air NextK183089 · 510(k) | NuvoAir AB | BZG | database entry | |
| d-Nav SystemK181916 · 510(k) | Hygieia, Inc | NDC | database entry | |
| MATRx plusK163665 · 510(k) | Zephyr Sleep Technologies | MNR | database entry | |
| SnoreSoundsK150102 · 510(k) | APPIAN MEDICAL, INC. | MNR | database entry | |
| EndoTool SubQK142918 · 510(k) | MONARCH MEDICAL TECHNOLOGIES | NDC | database entry | |
| SLEEP SYSTEM FOR CLINICS & RESEARCHK955841 · 510(k) | COMPUMEDICS PTD LTD. | MNR | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.