# OSP: Uterine Electromyographic Monitor

- Device class: 2; regulation: 21 CFR 884.2720; FDA's rule: 510(k) required
- FDA decisions: 10
- 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)
- 2011: 3
- 2012: 1
- 2013: 1
- 2014: 2
- 2015: 1
- 2017: 1
- 2020: 1

## Most-cited predicates
- K112390: Monica AN24 (2012), cited by 4
- K101801: Monica AN24 (2011), cited by 4
- K140862: Monica Novii Wireless Patch System (2014), cited by 2
- K090145: Surecall Emg Labor Monitor (2011), cited by 2
- K142583: LaborView LV1000 (2015), cited by 1
- K112163: Monica IF24 (2011), cited by 1

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