FDA product code BXQ: Rhinoanemometer (Measurement Of Nasal Decongestion)
BXQ is the FDA product code for rhinoanemometer (measurement of nasal decongestion). It is a Class II device, regulated under 21 CFR 868.1800 and reviewed by the Anesthesiology panel. FDA has cleared 12 510(k) submissions under BXQ, 1 in the last five years, from 11 different applicants. The average 510(k) review took 197 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Rhinoanemometer (Measurement Of Nasal Decongestion) |
| Device class | Class II |
| Regulation | 21 CFR 868.1800 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BXQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 304 |
| 2022 | 1 | 98 |
Compare with all 510(k) review times · Search every BXQ clearance
Top BXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rhino Metrics A/S | 2 | 2002-10-04 |
| Pacificmd Biotech, LLC | 1 | 2022-10-05 |
| Sleep Group Solutions | 1 | 2017-11-09 |
| E. Benson Hood Lab, Inc. | 1 | 2002-07-26 |
| G.M. Instruments , Ltd. | 1 | 1998-09-30 |
6 more applicants have BXQ clearances. See the full list in Caduvo.
Most recent BXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221892 | Pacificmd Biotech, LLC | VISIONAIR | 2022-10-05 | 98 |
| K170071 | Sleep Group Solutions | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer | 2017-11-09 | 304 |
| K022311 | Rhino Metrics A/S | RHINOSTREAM RHINOMANOMETER MODULE | 2002-10-04 | 79 |
| K011329 | E. Benson Hood Lab, Inc. | ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER | 2002-07-26 | 451 |
| K000406 | Rhino Metrics A/S | RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE | 2000-04-17 | 70 |
Recalls for BXQ devices
openFDA lists no recalls for product code BXQ.
Frequently asked questions
What is FDA product code BXQ?
BXQ is the FDA product code for rhinoanemometer (measurement of nasal decongestion). It is a Class II device, regulated under 21 CFR 868.1800 and reviewed by the Anesthesiology panel.
What device class is BXQ?
Class II, regulation 21 CFR 868.1800. Typical premarket route: 510(k).
How long does a 510(k) take for product code BXQ?
Across 12 cleared submissions the average was 197 days from receipt to decision (median 92).
Which companies have the most BXQ clearances?
Rhino Metrics A/S (2); Pacificmd Biotech, LLC (1); Sleep Group Solutions (1); E. Benson Hood Lab, Inc. (1); G.M. Instruments , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXQ
- Run a recall and safety report across every BXQ manufacturer
- Watch product code BXQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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