# KYF: Implant, Eye Valve

- Device class: 2; regulation: 21 CFR 886.3920; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 37 days (middle half 33–123)
- Recalls: 5 (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)
- 1999: 1
- 2002: 1
- 2003: 1
- 2006: 2
- 2015: 1
- 2016: 2
- 2017: 1
- 2019: 1
- 2022: 1
- 2023: 2

## Most-cited predicates
- K905129: Baerveldt Glaucoma Implant (1991), cited by 3
- K925636: Ahmed Glaucoma Valve Implant (1993), cited by 3
- K162060: Ahmed Glaucoma Valve (2016), cited by 2
- K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions (2002), cited by 2
- K980657: Ahmed Glaucoma Valve, Model S3 (1998), cited by 2
- K955455: Baervelt Pars Plana Glaucoma Implant (1997), cited by 2
- K875099: Molteno Valve Seton (1988), cited by 2
- K171451: Ahmed Glaucoma Valve Model FP8 (2017), cited by 1
- K161457: XEN Glaucoma Treatment System (2016), cited by 1
- K062252: MOLTENO3 (2006), cited by 1

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