# LBE: Stroller, Adaptive

- Device class: 1; regulation: 21 CFR 890.3850; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 281 days (middle half 281–281)
- 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)
- 1978: 1
- 1981: 1
- 1982: 1
- 1984: 1
- 1986: 2
- 2013: 1
- 2023: 1

## Most-cited predicates
- K810676: Convaid Cruiser CP4M (1981), cited by 1

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