# QRC: Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

- Device class: 2; regulation: 21 CFR 876.5026; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 189 days (middle half 170–209)
- 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)
- 2021: 1
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K223595: vPATCH (2023), cited by 2
- DEN210012: vPatch (2021), cited by 1

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