# OVB: Hydrogel Spacer

- Device class: 2; regulation: 21 CFR 892.5725; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 208 days (middle half 145–270)
- 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)
- 2015: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2022: 1
- 2023: 1
- 2026: 2

## Most-cited predicates
- DEN140030: SpaceOAR System (2015), cited by 3
- K182971: SpaceOAR Vue Hydrogel (2019), cited by 2
- K181465: SpaceOAR System (2018), cited by 2
- K202224: SpaceOAR System (2020), cited by 1

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