# NFM: Expander, Tissue, Orbital

- Device class: 2; regulation: 21 CFR 886.3320; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2001: 1
- 2006: 1

## Most-cited predicates
- K010852: Osmed Tissue Expander (2001), cited by 1
- K060151: Orbital Tissue Expander (Ote) (2006), cited by 1

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