510(k) · Cleared
ClearedEccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E. Benson Hood Lab, Inc. · BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)
Cleared on Jul 26, 2002 after a 451-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jul 26, 2002
- Review
- 451 days
- Class
- Class II
- Product code
- BXQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK011329 Eccovision Acoustic Diagnostic Imaging Acoustic PharyngometerE. Benson Hood Lab, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK092611 Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK170071 SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS…Sleep Group Solutions · 2017
- Descendant · 2 generations on · 1 of its ownK143042 SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK221892 VisionairPacificmd Biotech, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK193058 SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · Recalled (Class I)
Class I recalls in this family
- K193058 SonarMed AirWave Airway Monitoring System3 generations on · 2020
Most influential descendants
Showing 5 of 5 · See all- K092611Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010 · cites it directly2descendants
- K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…Sleep Group Solutions · 2017 · cites it directly1descendant
- K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · 2 generations on1descendant
- K221892VisionairPacificmd Biotech, LLC · 2022 · 2 generations on0descendants
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011329 | Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer | E. Benson Hood Lab, Inc. | 2002 | — |
| +1 | K092611 | Sonarmed Airway Monitoring System, Model 0901 | Sonarmed, Inc. | 2010 | — |
| +1 | K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM… | Sleep Group Solutions | 2017 | — |
| +2 | K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | 2016 | 1 |
| +2 | K221892 | Visionair | Pacificmd Biotech, LLC | 2022 | — |
| +3 | K193058 | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 1 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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 BXQ device
- #1 K221892 Visionairscore 4.4 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K092611 (Sonarmed, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BXQ devicesBXQ Rhinoanemometer (Measurement Of Nasal Decongestion): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BXQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · BXQ
Too few BXQ 510(k)s in any year since 2007 to give a median.
Recalls per year · BXQ
No recall names BXQ since 2007.
Adverse event reports per year · BXQ
No MAUDE report names BXQ since 2007.
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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011329: Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011329
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026