FDA product code OQU: Airway Monitoring System
OQU is the FDA product code for airway monitoring system. It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under OQU. The average 510(k) review took 299 days (median 245). FDA has posted 6 recalls for OQU devices, 5 initiated in the last five years.
Definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Classification
| Field | Value |
|---|---|
| Device name | Airway Monitoring System |
| Device class | Class II |
| Regulation | 21 CFR 868.5730 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for OQU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 196 |
Compare with all 510(k) review times · Search every OQU clearance
Top OQU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sonarmed, Inc. | 3 | 2020-05-15 |
Most recent OQU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193058 | Sonarmed, Inc. | SonarMed AirWave Airway Monitoring System | 2020-05-15 | 196 |
| K143042 | Sonarmed, Inc. | SonarMed AirWave, Airway Monitoring System | 2016-01-22 | 457 |
| K092611 | Sonarmed, Inc. | SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 | 2010-04-28 | 245 |
Recalls for OQU devices
6 product recalls in 4 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-03-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
| 2024 | 4 |
Frequently asked questions
What is FDA product code OQU?
OQU is the FDA product code for airway monitoring system. It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel.
What device class is OQU?
Class II, regulation 21 CFR 868.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQU?
Across 3 cleared submissions the average was 299 days from receipt to decision (median 245).
Which companies have the most OQU clearances?
Sonarmed, Inc. (3).
Have OQU devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2024-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code OQU
- Run a recall and safety report across every OQU manufacturer
- Watch product code OQU 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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