# FCO: Box, Battery, Rechargeable

- Device class: 1; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 20
- 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)
- 1993: 1
- 1994: 8
- 1995: 11

## Most-cited predicates
- K945869: R&D Part Nos. 5443, 5322, 5448, 5492 (1995), cited by 1
- K942018: R&D Batteries, Part NO. 5025, 5128 and 5183 (1994), cited by 1

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