510(k) · Cleared
ClearedSonarmed Airway Monitoring System, Model 0901
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 Apr 28, 2010 as substantially equivalent to K011329 (E. Benson Hood Lab, Inc., 2002) and 4 other predicates after a 245-day review. Its family tree reaches back 4 generations to 1982. 2 of the 15 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Apr 28, 2010
- Review
- 245 days
- Class
- Class II
- Product code
- OQU
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K822082 (1982). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK822082 Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · Recalled (Class I)
- 3 generations backK984528 Parker Flex-Tip Tracheal TubeParker Medical Assoc. · 1999 · Recalled
- 2 generations backK052233 Tracheoscopic Ventilation Tube (TVT) SystemEtview, Ltd. · 2005
- 1 generation backK082420 Tracheoscopic Ventilation Tube (TVT)Etview · 2008
- This deviceK092611 Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK143042 SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK193058 SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822082 | Sheridan/HVT,CF, Uncuffed | Sheridan Catheter Corp. | 1982 | Class I |
| −3 | K984528 | Parker Flex-Tip Tracheal Tube | Parker Medical Assoc. | 1999 | 1 |
| −2 | K052233 | Tracheoscopic Ventilation Tube (TVT) System | Etview, Ltd. | 2005 | — |
| −1 | K082420 | Tracheoscopic Ventilation Tube (TVT) | Etview | 2008 | — |
| 0 (this device) | K092611 | Sonarmed Airway Monitoring System, Model 0901 | Sonarmed, Inc. | 2010 | — |
| +1 | K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | 2016 | 1 |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K011329 | Eccovision Acoustic Diagnostic Imaging Acoustic PharyngometerSummary page 1…g System Name Product Code OQU Classification 21 CFR 868.5730 Number Predicate Eccovision Acoustic Devices Diagnostic Imaging K01 1329 BXQ 868.1800 Pharyngometer ETView Tracheoscopic K082420… | 2002 |
| * | K082420 | Tracheoscopic Ventilation Tube (TVT)Summary page 1…Diagnostic Imaging K01 1329 BXQ 868.1800 Pharyngometer ETView Tracheoscopic K082420 BTR 868.5730 Ventilation Tube PosiTube Esophageal K00004… | 2008 |
| * | K000045 | PositubeSummary page 1…ETView Tracheoscopic K082420 BTR 868.5730 Ventilation Tube PosiTube Esophageal K000045 BTR 868.5730 Intubation Detection RhinoScan Acoustic K0… | 2000 |
| * | K000406 | Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry ModuleSummary page 1…PosiTube Esophageal K000045 BTR 868.5730 Intubation Detection RhinoScan Acoustic K000406 BXQ 868.1800 Rhinometry Tidal Wave SP K032971… | 2000 |
| * | K032971 | Tidal Wave SP Model 710/715 and 715Summary page 1…RhinoScan Acoustic K000406 BXQ 868.1800 Rhinometry Tidal Wave SP K032971 DQA 870.2700 Model 710/715 Device The SonarMed AMS is comprised of a SonarMe… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143042 | SonarMed AirWave, Airway Monitoring System | 2016 | 1 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 28 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- 5 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143042 (Sonarmed, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K011329.
How does its category compare?
All OQU devicesOQU Airway Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092611: Sonarmed Airway Monitoring System, Model 0901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092611
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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