# INI: Vehicle, Motorized 3-Wheeled

- Device class: 2; regulation: 21 CFR 890.3800; FDA's rule: 510(k) required
- FDA decisions: 355
- 510(k) review time 2021–2025: median 127 days (middle half 86–239)
- Recalls: 19 (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)
- 2017: 5
- 2018: 3
- 2019: 4
- 2020: 1
- 2021: 5
- 2022: 6
- 2023: 9
- 2024: 8
- 2025: 15
- 2026: 21

## Most-cited predicates
- K051538: Avanticare, Model SA4022 (2005), cited by 8
- K072630: Foru, Model EQ30 (2007), cited by 7
- K013763: Wu's 4-Wheeled Neo Scooter, WT-L4 (2002), cited by 6
- K043326: Bewell, Model SC 20 (2005), cited by 6
- K201196: Scooter (Model: FDB01) (2021), cited by 6
- K032488: Wu's 3-Wheeled Neo Scooter, WT-T3D (2003), cited by 6
- K182471: Scooter (2019), cited by 5
- K231428: Mobility Scooter (Models: W3431D) (2023), cited by 5
- K110165: Freerider Model Luggie Model 168-4IT (2011), cited by 4
- K172440: Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 (2018), cited by 4

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