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 Medi-Tate , Ltd. and Prodeon Medical, Inc..
4
Total
3
Cleared
166d
Avg days
2020
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
90d
recently vs 243d historically
FDA 510(k) Cleared Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia Devices (Product Code QKA)
4 devices
Cleared
Mar 12, 2026
Urocross Expander System (Model Numbers ES2018 and ES3025)
Prodeon Medical, Inc.
Gastroenterology & Urology
119d
Cleared
Jun 25, 2021
iTind System
Medi-Tate , Ltd.
Gastroenterology & Urology
157d
Not Cleared
Feb 25, 2020
iTind System
Medi-Tate , Ltd.
Gastroenterology & Urology
329d
About Product Code QKA - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QKA since 2020, with 3 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QKA Product Code
Recent submissions under QKA have taken an average of 90 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 →