FDA product code QGK: Balloon, Nasal Airway
QGK is the FDA product code for balloon, nasal airway. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under QGK. The average 510(k) review took 164 days (median 164).
Definition
The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.
Classification
| Field | Value |
|---|---|
| Device name | Balloon, Nasal Airway |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QGK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 164 |
Compare with all 510(k) review times · Search every QGK clearance
Top QGK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acclarent, Inc. | 1 | 2019-04-19 |
Most recent QGK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183090 | Acclarent, Inc. | Relieva Tract Balloon Dilation System | 2019-04-19 | 164 |
Recalls for QGK devices
openFDA lists no recalls for product code QGK.
Frequently asked questions
What is FDA product code QGK?
QGK is the FDA product code for balloon, nasal airway. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is QGK?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QGK?
Across 1 cleared submissions the average was 164 days from receipt to decision (median 164).
Which companies have the most QGK clearances?
Acclarent, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGK
- Run a recall and safety report across every QGK manufacturer
- Watch product code QGK 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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