# OQY: Intrauterine Tamponade Balloon

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 30 days (middle half 29–130)
- Recalls: 2 (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: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (2017), cited by 4
- K150573: ebb Complete Tamponade System (2015), cited by 1
- K212757: Jada System (2021), cited by 1
- K201199: Jada System (2020), cited by 1
- K091958: Belfort-Dildy Obstetric Tamponade System (2010), cited by 1

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