# KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

- Device class: 2; regulation: 21 CFR 876.5320; FDA's rule: 510(k) required
- FDA decisions: 97
- 510(k) review time 2021–2025: median 197 days (middle half 152–257)
- 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)
- 2017: 1
- 2018: 3
- 2019: 2
- 2020: 1
- 2021: 3
- 2022: 3
- 2023: 3
- 2024: 4
- 2025: 4
- 2026: 7

## Most-cited predicates
- K891773: Microgyn II Elec Stim Device Treat of Urin Inconti (1989), cited by 9
- K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc (1995), cited by 7
- K110179: Incontrol (2012), cited by 7
- K181497: HPM-6000UF (2018), cited by 6
- K960496: Liberty Lite PFS System (1996), cited by 6
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer (1997), cited by 5
- K141643: Yarlap (2015), cited by 5
- K961872: Incare Pelvic Floor Therapy System with Desktop Computer (1996), cited by 5
- K053434: Myotrac Infiniti Electrical Stimulator (2006), cited by 4
- K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 (2000), cited by 4

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