# LPN: Accessories, Soft Lens Products

- Device class: 2; regulation: 21 CFR 886.5928; FDA's rule: 510(k) required
- FDA decisions: 123
- 510(k) review time 2021–2025: median 151 days (middle half 130–183)
- 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)
- 2012: 2
- 2013: 2
- 2015: 2
- 2016: 3
- 2017: 1
- 2019: 2
- 2020: 3
- 2021: 2
- 2022: 2
- 2026: 1

## Most-cited predicates
- K003345: Aosept Plus Cleaning and Disinfecting Solution (2001), cited by 6
- K013512: Aosept Clear Care Cleaning and Disinfecting Solution (2001), cited by 5
- K030522: Aosept Clear Care Cleaning and Disinfecting Solution (2003), cited by 5
- K031521: Aosept Clear Care Cleaning and Disinfecting Solution (2003), cited by 4
- K151768: Menicon Saline Rinse Solution (2015), cited by 4
- K974723: Renu Multiplus Multi-Purpose Solution (1998), cited by 4
- K852386: Soft Mate Automatic Contact Lens Cleaning Unit (1985), cited by 4
- K992028: Refresh Contacts Lubricating and Rewetting Drops (1999), cited by 3
- K002319: Purilens Saline Solution (2000), cited by 3
- K110221: Eye-Cept Sterile Saline Solution (2011), cited by 3

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