510(k) · Cleared
ClearedVisionair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacificmd Biotech, LLC · BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)
Cleared on Oct 5, 2022 as substantially equivalent to K170071 (Sleep Group Solutions, 2017) after a 98-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Oct 5, 2022
- Review
- 98 days
- Class
- Class II
- Product code
- BXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921452 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921452 | Acoustic Rhinometer | Hood Laboratories | 1993 | — |
| −1 | K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM… | Sleep Group Solutions | 2017 | — |
| 0 (this device) | K221892 | Visionair | Pacificmd Biotech, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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.
Planning a device in BXQ? 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 |
|---|---|---|---|
| * | K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…Summary page 5…ndary Code: EOB Primary Review Panel: Anesthesia [807.92(a)(3)] Legally Marketed Devices Primary Predicate Eccovision™ System (K170071) Device: Smith & Nephew Image Video System (K970247) Reference Device: [807.92(a)(4)] Device Descrip… | 2017 |
| † | K970247 | Smith & Nephew Images Arthroscope/Ent Endoscope | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 24.3 years on median.
- None of the 3 ancestors has a recall.
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. 2022, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221892 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221892: Visionair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221892
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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