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Sign in to claim this brandSonarmed, Inc.
US
Last updated May 23, 2026
What Sonarmed, Inc. makes
Sonarmed, Inc. manufactures the SonarMed AirWave, an endotracheal secretion monitoring system designed to detect and assess airway secretions in patients under mechanical ventilation. The device uses ultrasound technology to provide real-time monitoring of mucus accumulation, helping to prevent complications such as ventilator-associated pneumonia.
The SonarMed AirWave is classified as a Class II medical device under FDA regulations and is authorised through the 510(k) and Unique Device Identifier (UDI) processes. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sonarmed, Inc. manufacture?
Sonarmed, Inc. specializes in endotracheal secretion monitoring systems. Their primary device, the SonarMed AirWave, uses ultrasound technology to continuously monitor mucus accumulation in patients on mechanical ventilation, helping to reduce risks like ventilator-associated pneumonia. This focus on airway monitoring distinguishes their product from broader ventilator or respiratory support systems.
Where is Sonarmed, Inc. based, and how does that affect its regulatory approach?
Sonarmed, Inc. is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s products are authorised through the FDA’s 510(k) pathway and must comply with Unique Device Identifier (UDI) requirements, ensuring traceability and regulatory tracking for Class II devices like the SonarMed AirWave.
Which regulatory registries or databases list Sonarmed, Inc.’s devices?
Sonarmed, Inc.’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure transparency in device authorisation, classification, and compliance with U.S. medical device regulations, particularly for Class II products like the SonarMed AirWave.
How are Sonarmed, Inc.’s devices classified under FDA regulations?
The SonarMed AirWave is classified as a Class II medical device by the FDA. This classification is based on its intended use—monitoring endotracheal secretions—and its moderate risk level, which requires special controls beyond general controls to ensure safety and effectiveness. Class II devices undergo a 510(k) premarket submission to demonstrate substantial equivalence to a legally marketed predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 198245628
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SonarMed AirWave | AW-S075 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S045 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S055 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0007 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S050 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-M0001 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S030 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0003 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S035 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0001 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0004 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0012 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0006 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S065 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0013 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S040 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0005 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-SC05 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0002 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0014 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S025 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S0015 | FDA UDI | Class II | Active |
| SonarMed AirWave | AW-S085 | FDA UDI | Class II | Active |
| SonarMed AirWave Airway Monitoring System | K193058 | FDA 510(k) | Class II | Active |
| Sonarmed Airway Monitoring System, Model 0901 | K092611 | FDA 510(k) | Class II | Active |
| SonarMed AirWave, Airway Monitoring System | K143042 | FDA 510(k) | Class II | Active |
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Sonarmed, Inc. has five FDA recall records initiated between April 17, 2017, and March 25, 2024. The records include instances classified as open, terminated, and classified, with reasons involving sensor detection failures—specifically, the inability to detect partial obstructions in 2.5mm and up to 3mm sensors—and a software anomaly causing potential inoperability of monitors due to conflicting error codes.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 25, 2024 | Z-1535-2024 | — | open, classified | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. |
| Mar 21, 2024 | Z-1519-2024 | — | open, classified | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 21, 2024 | Z-1520-2024 | — | open, classified | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 21, 2024 | Z-1521-2024 | — | open, classified | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Apr 17, 2017 | Z-2450-2019 | — | terminated | Potential for the presence of two error codes which would make the monitor inoperable. |