# PHU: Intra-Abdominal Pressure Monitoring Device

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 245 days (middle half 245–245)
- 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)
- 2007: 1
- 2021: 1

## Most-cited predicates
- K070201: Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001 (2007), cited by 1
- K210570: TraumaGuard Intra-abdominal Pressure Sensing System (2021), cited by 1

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