FDA product code QNA: Ultrasonic Urinary Stone Propulsion Device
QNA is the FDA product code for ultrasonic urinary stone propulsion device. It is a Class II device, regulated under 21 CFR 876.4690 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QNA, 1 in the last five years. The average 510(k) review took 30 days (median 30); 30 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasonic Urinary Stone Propulsion Device |
| Device class | Class II |
| Regulation | 21 CFR 876.4690 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QNA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every QNA clearance
Top QNA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sonomotion, Inc. | 1 | 2026-07-29 |
Most recent QNA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262200 | Sonomotion, Inc. | Stone Clear (BWSC-LP9-02) | 2026-07-29 | 30 |
Recalls for QNA devices
openFDA lists no recalls for product code QNA.
Frequently asked questions
What is FDA product code QNA?
QNA is the FDA product code for ultrasonic urinary stone propulsion device. It is a Class II device, regulated under 21 CFR 876.4690 and reviewed by the Gastroenterology and Urology panel.
What device class is QNA?
Class II, regulation 21 CFR 876.4690. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNA?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most QNA clearances?
Sonomotion, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QNA
- Run a recall and safety report across every QNA manufacturer
- Watch product code QNA 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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