QKA · Class II · 21 CFR 876.5510

FDA Product Code QKA: Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

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.

Leading manufacturers include Prodeon Medical, Inc..

3
Total
2
Cleared
202d
Avg days
2020
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 119d recently vs 243d historically

FDA 510(k) Cleared Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia Devices (Product Code QKA)

3 devices
1–3 of 3
Cleared Mar 12, 2026
Urocross Expander System (Model Numbers ES2018 and ES3025)
K253525
Prodeon Medical, Inc.
Gastroenterology & Urology · 119d

About Product Code QKA - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QKA since 2020, with 2 receiving FDA clearance (average review time: 202 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QKA have taken an average of 119 days to reach a decision - down from 243 days historically, suggesting improved FDA processing for this classification.

QKA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →