# HIR: Perineometer

- Device class: 2; regulation: 21 CFR 884.1425; FDA's rule: 510(k) required
- FDA decisions: 65
- 510(k) review time 2021–2025: median 129 days (middle half 30–197)
- 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)
- 2016: 1
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 2
- 2021: 3
- 2022: 1
- 2023: 3
- 2024: 2
- 2026: 1

## Most-cited predicates
- K002830: Pelvic Muscle Therapy (2000), cited by 4
- K940091: Innova Vaginal Emg Sensing Electrode (1994), cited by 3
- K891774: Contimed II Biofeedback Dev Treat of Urin Inconti (1989), cited by 3
- K952688: Innova Rectal or Small Vaginal Emg Sensing Electrode (1995), cited by 3
- K911190: Perrymeter (TM) (1991), cited by 2
- K021115: Gyneflex (2002), cited by 2
- K945611: Peritron (1996), cited by 1
- K212495: Leva Pelvic Health System (2021), cited by 1
- K133990: Ieva Rehabilitative Positional Device (2014), cited by 1
- K162689: Vibrance Pelvic Trainer (2017), cited by 1

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