510(k) · Cleared
ClearedRhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhino Metrics A/S · BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)
Cleared on Apr 17, 2000 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 17, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- BXQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK000406 Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry ModuleRhino Metrics A/S · 2000
- Descendant · cites it directly · 2 of its ownK092611 Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK143042 SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · Recalled
- 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 3 of 3 · See all- K092611Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010 · cites it directly2descendants
- K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · 2 generations on1descendant
- 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) | K000406 | Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module | Rhino Metrics A/S | 2000 | — |
| +1 | K092611 | Sonarmed Airway Monitoring System, Model 0901 | Sonarmed, Inc. | 2010 | — |
| +2 | K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | 2016 | 1 |
| +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 |
| 2020 | 1 | 1 |
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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092611 | Sonarmed Airway Monitoring System, Model 0901 | 2010 | 2 |
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/K000406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000406: Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000406
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026