# MSS: Folders And Injectors, Intraocular Lens (Iol)

- Device class: 1; regulation: 21 CFR 886.4300; FDA's rule: 510(k) required
- FDA decisions: 63
- 510(k) review time 2021–2025: median 54 days (middle half 40–58)
- 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)
- 2016: 2
- 2017: 3
- 2018: 1
- 2019: 3
- 2020: 2
- 2021: 1
- 2023: 3
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K003768: Monarch II Iol Delivery System (2001), cited by 6
- K113852: Bausch & Lomb Iol Injector (2012), cited by 5
- K040837: Multiject Injector and Microglide Cartridge (2004), cited by 4
- K970727: Mport Foldable Lens Placement System (1997), cited by 4
- K131958: Bausch & Lomb Injector System (2014), cited by 3
- K092023: Naviject SUB2-1P, Model: LP604430 (2009), cited by 3
- K980696: Foam Tip Injector (1998), cited by 3
- K172228: pioli IOL Delivery System (2017), cited by 2
- K231466: RxSight Insertion Device (2023), cited by 2
- K002556: Ceeon Easysert Intraocular Lens Injector, Model Imp-1 (2000), cited by 2

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