Sonarmed AirWave Airway Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193058 FDA 510(k)
- FDA Product Code
- OQU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5730 FDA 510(k)
- Regulation Number
- 868.5730 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sonarmed AirWave Airway Monitoring System is a Class II airway monitoring device designed to assess endotracheal tube (ETT) position and detect obstructions in real time. It employs acoustic technology to provide continuous, non-invasive monitoring of airway patency, supporting critical care and anesthesia applications.
This system is intended for use in clinical settings by qualified personnel, such as anesthesiologists, and is supplied as a reusable device. It operates under FDA 510(k) clearance (K193058) and adheres to regulatory standards for airway monitoring (CFR 868.5730). Storage and maintenance instructions are detailed in the operator’s manual, ensuring proper functionality and compliance with medical device regulations.
Frequently asked questions
How does the Sonarmed AirWave Airway Monitoring System differ from traditional methods of monitoring endotracheal tube placement and airway patency?
The AirWave system uses acoustic technology to provide real-time, non-invasive monitoring of endotracheal tube (ETT) position and airway obstructions, unlike traditional methods that rely on intermittent visual checks, auscultation, or capnography. This continuous monitoring is particularly useful in critical care and anesthesia settings where immediate detection of dislodgment or obstruction is critical. The device is designed for qualified personnel, such as anesthesiologists, to enhance patient safety during procedures.
Is the Sonarmed AirWave Airway Monitoring System intended for single-use or reusable applications, and what does this mean for maintenance?
The AirWave system is explicitly described as a reusable device, meaning it is designed for repeated use in clinical settings after proper cleaning, maintenance, and sterilization. Since it is reusable, maintenance protocols—such as cleaning, calibration, and storage—must follow the manufacturer’s guidelines outlined in the operator’s manual to ensure accurate and reliable performance over time. This contrasts with single-use devices, which are discarded after one procedure.
What clinical specialties or settings is the Sonarmed AirWave Airway Monitoring System primarily intended for, and why?
The AirWave system is primarily intended for critical care and anesthesia applications, as indicated by its FDA 510(k) clearance under the Anesthesiology advisory committee (AN) and regulatory classification under CFR 868.5730. Its acoustic technology is particularly valuable in these settings because it provides continuous, non-invasive monitoring of ETT position and airway patency, reducing the need for frequent manual checks during high-stakes procedures like intubations or ventilator management.
How should the Sonarmed AirWave Airway Monitoring System be stored, and are there any specific regulatory considerations for its handling?
Storage instructions for the AirWave system are detailed in the operator’s manual, which ensures compliance with medical device regulations. While the manual does not specify storage conditions in the provided data, reusable devices like this typically require protection from moisture, extreme temperatures, and physical damage to maintain functionality. Since it is a Class II device cleared under FDA 510(k), adherence to manufacturer guidelines is essential not only for performance but also to meet regulatory expectations for device maintenance and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SONARMED AIRWAVE OPERATOR'S MANUAL Pdf Download, Sonarmed AirWave Manuals | ManualsLib, Media Kits | Medtronic, Class 1 Device Recall SonarMed AirWave - Food and Drug Administration, PDF SonarMed, Inc. Laura Lyons VP Compliance & Respiratory Care Trade ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193058 | Class II | Active |
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Manufacturer
- Manufacturer
- Sonarmed, Inc.
Sources (1)
- FDA 510(k) K193058 24 fields · synced Oct 6, 2026