# KYB: Lens, Guide, Intraocular

- Device class: 1; regulation: 21 CFR 886.4300; FDA's rule: 510(k) exempt
- FDA decisions: 39
- Recalls: 6 (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)
- 1995: 3
- 1996: 1
- 1997: 2
- 1998: 2
- 2000: 1
- 2002: 1
- 2004: 1
- 2007: 3
- 2008: 2
- 2015: 1

## Most-cited predicates
- K063155: Monarch Iii Iol Delivery System (2007), cited by 7
- K961242: Amo Phacoflex II Intersection System (1996), cited by 4
- K001157: Monarch II Iol Delivery System (2000), cited by 3
- K940593: Disposable Microstaar Injector (1994), cited by 2
- K903574: Chiroflex Lens Microsert (1990), cited by 2
- K983129: Disposable Microstaar Injector (Model Msi-P1) (1998), cited by 2
- K941603: Amo Phacoflex Inserter Disposable Cartridge, and Handpiece (1994), cited by 1
- K070669: Iol Injector Set (2007), cited by 1
- K954600: Microstaar Injector Models Msi-TD & Msi-PD (Modification) (1995), cited by 1
- K861085: Elastic Lens Injector TM (1986), cited by 1

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