# K092611: Sonarmed Airway Monitoring System, Model 0901

- Pathway: 510(k) (Traditional)
- Applicant: Sonarmed, Inc.
- Decided: Apr 28, 2010 after 245 days
- Product code: OQU (Airway Monitoring System)
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K822082 (1982). 12 ancestors in all.
2 later devices descend 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)
- K011329: Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer, E. Benson Hood Lab, Inc. (2002) Summary page 1.
- K082420: Tracheoscopic Ventilation Tube (TVT), Etview (2008) Summary page 1.
- K000045: Positube, Paraproducts, Inc. (2000) Summary page 1.
- K000406: Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module, Rhino Metrics A/S (2000) Summary page 1.
- K032971: Tidal Wave SP Model 710/715                                       and 715, Respironics Novametrix, Inc. (2004) Summary page 1.

## Most influential descendants
- K143042: SonarMed AirWave, Airway Monitoring System (2016), 1 descendant of its own
- K193058: SonarMed AirWave Airway Monitoring System (2020), 0 descendants of its own

## Indications for use
The SonarMed TM AMS is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, and to assist in detecting obstruction of the ETT. The SonarMed AMS is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital selling (intensive care, operating room, and emergency department settings, as well as intra-hospital transport). The SonarMed AMS 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 from 6.5 mm to 9.0 mm, with a body weight of >35 kg.

Source page: https://510kreport.com/device/K092611
Methodology: https://510kreport.com/methodology