# OMR: Vessel Guard Or Cover

- Device class: 2; regulation: 21 CFR 870.3470; FDA's rule: 510(k) required
- FDA decisions: 10
- 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)
- 2009: 3
- 2010: 3
- 2011: 3
- 2012: 1

## Most-cited predicates
- K090022: Paradis Vaso Shield (2009), cited by 4
- K093551: Paradis Vaso Shield (2009), cited by 3
- K082782: Replication Medical Vessel Guard (2009), cited by 3
- K103558: Synthes Scout Vessel Guard (2011), cited by 1
- K100905: Hydrofix Surgical Sheet (2010), cited by 1

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