510(k) · Cleared
Recalled · Class II · 2017SonarMed AirWave, Airway Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonarmed, Inc. · OQU Airway Monitoring System
Cleared on Jan 22, 2016 as substantially equivalent to K092611 (Sonarmed, Inc., 2010) after a 457-day review. Its family tree reaches back 5 generations to 1982. 2 of the 15 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 22, 2016
- Review
- 457 days
- Class
- Class II
- Product code
- OQU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K822082 (1982). 13 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 4 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 3 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 2 generations backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- 1 generation backK092611 Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010
- This deviceK143042 SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK193058 SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −4 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −3 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −2 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| −1 | K092611 | Sonarmed Airway Monitoring System, Model 0901 | Sonarmed, Inc. | 2010 | — |
| 0 (this device) | K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | 2016 | — |
| +1 | K193058 | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | 2020 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OQU device
- #1 K193058 SonarMed AirWave Airway Monitoring Systemscore -13.2 · 6 generations · Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092611 | Sonarmed Airway Monitoring System, Model 0901Summary page 4…l Tube Adapter Name Product Code OQU Classification Tracheal Tube Name Classification 21 CFR 868.5730 Number Predicate SonarMed Airway K092611 OQU 868.5730 Device Management System Device The SonarMed AirWave is comprised of a… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193058 | SonarMed AirWave Airway Monitoring System Class I | 2020 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2017 | Class II | Z-2450-2019 | Software design | Potential for the presence of two error codes which would make the monitor inoperable. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 5 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K193058 (Sonarmed, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OQU devicesOQU Airway Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OQU
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OQU
Too few OQU 510(k)s in any year since 2007 to give a median.
Recalls per year · OQU
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQU
7in 2024
MAUDE reports naming product code OQU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (135 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143042: SonarMed AirWave, Airway Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143042
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026