# QKA: Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

- Device class: 2; regulation: 21 CFR 876.5510; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 157 days (middle half 157–157)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2020: 1
- 2021: 1
- 2026: 2

## Most-cited predicates
- DEN190020: iTind System (2020), cited by 2
- K253525: Urocross Expander System (Model Numbers ES2018 and ES3025) (2026), cited by 1

Source page: https://510kreport.com/product-code/QKA
Data by year (CSV): https://510kreport.com/product-code/QKA.csv