# OXH: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 140 days (middle half 84–195)
- 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)
- 2015: 1
- 2016: 1
- 2017: 1
- 2021: 1
- 2025: 1

## Most-cited predicates
- K202430: Kerecis Reconstruct (2021), cited by 3
- K150341: Miromatrix Biological Mesh RS (2015), cited by 1

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