# OMD: Cutaneous Tissue Adhesive With Mesh

- Device class: 2; regulation: 21 CFR 878.4011; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 266 days (middle half 151–301)
- 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)
- 2010: 1
- 2014: 1
- 2015: 1
- 2017: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K133864: Dermabond Prineo Skin Closure System (2014), cited by 6
- DEN090005: Prineo Skin Closure System (2010), cited by 3
- K191461: Exofin Fusion Skin Closure System (2020), cited by 1
- K171442: Exofin Fusion Skin Closure System (2017), cited by 1

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