# SAM: Battery-Powered Instruments Charged Through Sterile Barriers

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) required
- FDA decisions: 1
- 510(k) review time 2021–2025: median 85 days (middle half 85–85)
- 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)
- 2024: 1

## Most-cited predicates

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