# KXO: Monitor, Pressure, Intrauterine

- Device class: 2; regulation: 21 CFR 884.2700; FDA's rule: 510(k) required
- FDA decisions: 26
- 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)
- 1989: 5
- 1990: 2
- 1991: 2
- 1992: 2
- 1994: 1
- 1995: 2
- 1996: 1
- 1997: 1
- 1998: 2
- 1999: 1

## Most-cited predicates
- K961290: Iup - Tip Trans, Iup - Proxi Trans (1996), cited by 1
- K964279: Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc) (1997), cited by 1
- K905563: Intran Plus (1991), cited by 1

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