# K143042: SonarMed AirWave, Airway Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sonarmed, Inc.
- Decided: Jan 22, 2016 after 457 days
- Product code: OQU (Airway Monitoring System)
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K822082 (1982). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092611: Sonarmed Airway Monitoring System, Model 0901, Sonarmed, Inc. (2010) Summary page 4.

## Most influential descendants
- K193058: SonarMed AirWave Airway Monitoring System (2020), 0 descendants of its own

## Recalls of this device
- Apr 17, 2017 · Class II · Z-2450-2019: Potential for the presence of two error codes which would make the monitor inoperable.

## 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 not to be used as a stand-alone diagnostic system. It is intended for use with patients who use ET tube sizes 2.5, 3.0, 3.5, and for sizes 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0 mm.

Source page: https://510kreport.com/device/K143042
Methodology: https://510kreport.com/methodology