510(k) · Cleared
Recalled · Class I · 2024SonarMed 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 May 15, 2020 as substantially equivalent to K143042 (Sonarmed, Inc., 2016) after a 196-day review. Its family tree reaches back 6 generations to 1982. 2 of the 15 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including 4 Class I recalls.
- Decided
- May 15, 2020
- Review
- 196 days
- Class
- Class II
- Product code
- OQU
- Recalls
- 5 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K822082 (1982). 14 ancestors in all. No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 5 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 4 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 3 generations backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- 2 generations backK092611 Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010
- 1 generation backK143042 SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · Recalled
- This deviceK193058 SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020
Class I recalls in this family
- K822082 Sheridan/HVT,CF, Uncuffed6 generations back · 1982
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −5 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −4 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −3 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| −2 | K092611 | Sonarmed Airway Monitoring System, Model 0901 | Sonarmed, Inc. | 2010 | — |
| −1 | K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | 2016 | 1 |
| 0 (this device) | K193058 | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | 2020 | — |
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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K143042 | SonarMed AirWave, Airway Monitoring SystemSummary page 4…toring System Name Classification 21 CFR 868.5730 Number Product Code OQU Predicate SonarMed Airway Device Management System K143042 OQU 868.5730 Page 1 of 6 === Page… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2024 | Class I | Z-1535-2024 | Device Design | 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 | Process control | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 21, 2024 | Class I | Z-1521-2024 | Process control | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Mar 21, 2024 | Class I | Z-1520-2024 | Process control | The failure to detect the partial obstruction in a 2.5mm sensor. |
| Dec 22, 2021 | Class II | Z-0514-2022 | Process control | 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 false sensor cable disconnect and… |
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.
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 6 generations back · ◆ on the line of descent in FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 38 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 6 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OQU devicesOQU Airway Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 (124 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 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193058: 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/K193058
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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