FDA product code QXM: Implanted Tibial Electrical Urinary Continence Device
QXM is the FDA product code for implanted tibial electrical urinary continence device. It is a Class II device, regulated under 21 CFR 876.5305 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under QXM, 3 in the last five years. The average 510(k) review took 167 days (median 134); 167 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.
Classification
| Field | Value |
|---|---|
| Device name | Implanted Tibial Electrical Urinary Continence Device |
| Device class | Class II |
| Regulation | 21 CFR 876.5305 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QXM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 118 |
| 2025 | 1 | 134 |
| 2026 | 1 | 250 |
Compare with all 510(k) review times · Search every QXM clearance
Top QXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bluewind Medical , Ltd. | 3 | 2026-07-28 |
Most recent QXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253651 | Bluewind Medical , Ltd. | Revi System | 2026-07-28 | 250 |
| K252391 | Bluewind Medical , Ltd. | Revi System | 2025-12-12 | 134 |
| K240037 | Bluewind Medical , Ltd. | Revi System | 2024-05-02 | 118 |
Recalls for QXM devices
openFDA lists no recalls for product code QXM.
Frequently asked questions
What is FDA product code QXM?
QXM is the FDA product code for implanted tibial electrical urinary continence device. It is a Class II device, regulated under 21 CFR 876.5305 and reviewed by the Gastroenterology and Urology panel.
What device class is QXM?
Class II, regulation 21 CFR 876.5305. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXM?
Across 3 cleared submissions the average was 167 days from receipt to decision (median 134).
Which companies have the most QXM clearances?
Bluewind Medical , Ltd. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QXM
- Run a recall and safety report across every QXM manufacturer
- Watch product code QXM 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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