FDA product code QZC: External Mechanical Stimulator For The Relief Of Congestion
QZC is the FDA product code for external mechanical stimulator for the relief of congestion. It is a Class II device, regulated under 21 CFR 874.6010 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under QZC, 1 in the last five years. The average 510(k) review took 269 days (median 269); 269 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
Classification
| Field | Value |
|---|---|
| Device name | External Mechanical Stimulator For The Relief Of Congestion |
| Device class | Class II |
| Regulation | 21 CFR 874.6010 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QZC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 269 |
Compare with all 510(k) review times · Search every QZC clearance
Top QZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sound Health Systems, Inc. | 1 | 2025-04-24 |
Most recent QZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242214 | Sound Health Systems, Inc. | Sonu | 2025-04-24 | 269 |
Recalls for QZC devices
openFDA lists no recalls for product code QZC.
Frequently asked questions
What is FDA product code QZC?
QZC is the FDA product code for external mechanical stimulator for the relief of congestion. It is a Class II device, regulated under 21 CFR 874.6010 and reviewed by the Ear, Nose and Throat panel.
What device class is QZC?
Class II, regulation 21 CFR 874.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZC?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most QZC clearances?
Sound Health Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZC
- Run a recall and safety report across every QZC manufacturer
- Watch product code QZC 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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