FDA product code QKA: Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
QKA is the FDA product code for temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 876.5510 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under QKA, 2 in the last five years, from 2 different applicants. The average 510(k) review took 112 days (median 119); 90 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Classification
| Field | Value |
|---|---|
| Device name | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Device class | Class II |
| Regulation | 21 CFR 876.5510 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QKA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 157 |
| 2026 | 2 | 90 |
Compare with all 510(k) review times · Search every QKA clearance
Top QKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prodeon Medical, Inc. | 2 | 2026-06-22 |
| Medi-Tate , Ltd. | 1 | 2021-06-25 |
Most recent QKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261342 | Prodeon Medical, Inc. | Urocross Expander System (UES-2018-C1) | 2026-06-22 | 60 |
| K253525 | Prodeon Medical, Inc. | Urocross Expander System (Model Numbers ES2018 and ES3025) | 2026-03-12 | 119 |
| K210138 | Medi-Tate , Ltd. | iTind System | 2021-06-25 | 157 |
Recalls for QKA devices
openFDA lists no recalls for product code QKA.
Frequently asked questions
What is FDA product code QKA?
QKA is the FDA product code for temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 876.5510 and reviewed by the Gastroenterology and Urology panel.
What device class is QKA?
Class II, regulation 21 CFR 876.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code QKA?
Across 3 cleared submissions the average was 112 days from receipt to decision (median 119).
Which companies have the most QKA clearances?
Prodeon Medical, Inc. (2); Medi-Tate , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QKA
- Run a recall and safety report across every QKA manufacturer
- Watch product code QKA 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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