# HFN: Transducer, Pressure, Intrauterine

- Device class: 2; regulation: 21 CFR 884.2700; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 58 days (middle half 58–58)
- Recalls: 1 (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: 2
- 1992: 1
- 1996: 3
- 1997: 1
- 1998: 1
- 2025: 1

## Most-cited predicates
- K974389: Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter (1998), cited by 1
- K954955: Storc Intrauterine Pressure Catheter (1996), cited by 1
- K955443: Intran Plus (1996), cited by 1

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