# PCT: Prostate Immobilizer Rectal Balloon

- Device class: 2; regulation: 21 CFR 892.5720; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 151 days (middle half 151–151)
- 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)
- 2014: 2
- 2015: 1
- 2018: 1
- 2023: 1

## Most-cited predicates
- DEN130036: Prostate Immobilizer Rectal Balloon (2014), cited by 4
- K150234: Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (2015), cited by 1

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