510(k) · Cleared
ClearedRhinostream Rhinomanometer 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 Oct 4, 2002 as substantially equivalent to K902120 (Life-Tech Intl., Inc., 1990) after a 79-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Oct 4, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- BXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902120 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902120 Mercury RhinomanometerLife-Tech Intl., Inc. · 1990
- This deviceK022311 Rhinostream Rhinomanometer ModuleRhino Metrics A/S · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902120 | Mercury Rhinomanometer | Life-Tech Intl., Inc. | 1990 | — |
| 0 (this device) | K022311 | Rhinostream Rhinomanometer Module | Rhino Metrics A/S | 2002 | — |
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.
Top candidate predicates for a new BXQ device
- #1 K221892 Visionairscore 4.4 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K902120 | Mercury RhinomanometerSummary page 2…Eauivalencv CI Darison Description Mercury Medical. Rhinomanometer Rhinostream Rhinomanometer (K) 902120 Device To provide rhinomanometry To provide rhinomanometry description… | 1990 |
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?
- Its one ancestor has no 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.
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?
A Rhinomanometer is a medical instrument, intended to measure nasal ainvay pressure up to 5 centimeters H 2 0. (500Pa) and air flow up to 1000 nilis.
This is a non-invasive procedure, which is useful to the physician in studying the nasal decongestion of the nasal passage as it e.g. changes due to allergies, before and after surgical procedures, responses to medications, presence or absence of polyps, deviated septums, enlarged adenoids, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022311: Rhinostream Rhinomanometer Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022311
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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