# MRC: Products, Contact Lens Care, Rigid Gas Permeable

- Device class: 2; regulation: 21 CFR 886.5918; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 113 days (middle half 113–113)
- Recalls: 3 (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)
- 2003: 2
- 2004: 1
- 2005: 1
- 2010: 1
- 2013: 2
- 2017: 2
- 2018: 3
- 2019: 1
- 2020: 2
- 2025: 1

## Most-cited predicates
- K023455: Aosept Clear Care Cleaning and Disinfecting Solution (2003), cited by 5
- K002140: Menicon Progent Remover (2000), cited by 3
- K181627: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (2018), cited by 2
- K024289: Boston BL-1000-SIM08 Multi-Action Solution (2003), cited by 2
- K974466: Boston Advance Cleaner (1998), cited by 2
- K000148: RGP Multi-Purpose Solution ID 100136 (2000), cited by 1
- K122273: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lens (2013), cited by 1
- K001964: Optimum Cleaning, Disinfecting and Storage Solution (2000), cited by 1
- K082855: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (2010), cited by 1
- K013204: Aquify Lens Comfort Drops (2002), cited by 1

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