# LRX: Case, Contact Lens

- Device class: 2; regulation: 21 CFR 886.5928; FDA's rule: 510(k) required
- FDA decisions: 82
- 510(k) review time 2021–2025: median 162 days (middle half 147–217)
- 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)
- 2012: 3
- 2013: 4
- 2014: 3
- 2015: 2
- 2016: 2
- 2017: 5
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K042578: I-Promotions Contact Lens Case (2005), cited by 5
- K013232: Cybercases by Bausch & Lomb (2001), cited by 4
- K071081: Contact Lens Case (2007), cited by 4
- K130930: Owl Contact Lens Cases, Dog Contact Lens Cases (2014), cited by 3
- K030987: Contact Lens Storage Case (2003), cited by 3
- K991206: Bonasse Contact Lens Case (2000), cited by 3
- K971618: Alcon Contact Lens Case (1997), cited by 3
- K093377: Polaris Contact Lens Case (2010), cited by 2
- K974635: Paragon Lens Care (1998), cited by 2
- K240095: CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (2024), cited by 2

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