# K193058: SonarMed AirWave Airway Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sonarmed, Inc.
- Decided: May 15, 2020 after 196 days
- Product code: OQU (Airway Monitoring System)
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 5 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K822082 (1982). 14 ancestors in all.
No later device cites it as a predicate yet.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143042: SonarMed AirWave, Airway Monitoring System, Sonarmed, Inc. (2016) Summary page 4.

## Recalls of this device
- Mar 25, 2024 · Class I · Z-1535-2024: 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 · Class I · Z-1519-2024: The failure to detect the partial obstruction in a 2.5mm sensor.
- Mar 21, 2024 · Class I · Z-1521-2024: The failure to detect the partial obstruction in a 2.5mm sensor.
- Mar 21, 2024 · Class I · Z-1520-2024: The failure to detect the partial obstruction in a 2.5mm sensor.
- Dec 22, 2021 · Class II · Z-0514-2022: Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a fa

## Indications for use
The SonarMed AirWave Airway Monitoring System is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds. The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport). The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice and is a not a stand-alone diagnostic system. It is intended for use with neonates, infants, children, adolescents, and adults (sizes 2.5 mm to 9.0 mm).

Source page: https://510kreport.com/device/K193058
Methodology: https://510kreport.com/methodology