# LZU: Plug, Punctum

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 155 days (middle half 106–160)
- 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)
- 2005: 1
- 2006: 2
- 2009: 1
- 2014: 3
- 2015: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2022: 2
- 2024: 1

## Most-cited predicates
- K946357: Collagen Intracanalicular Plug (1995), cited by 3
- K895342: Collagen Implants for the Lacrimal Efficiency Test (1989), cited by 3
- K030300: Opaque Herrick Lacrimal Plug (2003), cited by 3
- K890919: Temporary Intracanalicular Collagen Implant (1989), cited by 3
- K162361: Soft Plug Extended Duration 180 Canalicular Plug (2017), cited by 2
- K022043: Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503 (2002), cited by 2
- K040912: Hydrogel Canalicular Plug (2004), cited by 1
- K945906: Silicone Punctal Plug (1995), cited by 1
- K896175: Herrick Lacrimal Plug TM. (1990), cited by 1
- K021936: Moist Punctal Plug System (2002), cited by 1

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