Sonarmed, Inc.
Indianapolis, IN, US
Sonarmed, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Sonarmed, Inc. between 2010 and 2020. The busiest year on record is 2010, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193058 | SonarMed AirWave Airway Monitoring System | OQU | Substantially Equivalent | |
| K143042 | SonarMed AirWave, Airway Monitoring System | OQU | Substantially Equivalent | |
| K092611 | SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 | OQU | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1535-2024 | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. | Class I | Open, Classified | |
| Z-1521-2024 | AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring. | The failure to detect the partial obstruction in a 2.5mm sensor. | Class I | Open, Classified | |
| Z-1520-2024 | AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring. | The failure to detect the partial obstruction in a 2.5mm sensor. | Class I | Open, Classified | |
| Z-1519-2024 | AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring. | The failure to detect the partial obstruction in a 2.5mm sensor. | Class I | Open, Classified | |
| Z-2450-2019 | SonarMed AirWave Monitor, Model Number M0001 | Potential for the presence of two error codes which would make the monitor inoperable. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain