# OTZ: Graft Insertion Instrument For Endothelial Keratoplasty

- Device class: 1; regulation: 21 CFR 886.4300; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 421 days (middle half 421–421)
- Recalls: 0 (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)
- 2011: 2
- 2012: 2
- 2022: 1

## Most-cited predicates
- K090626: Endoserter (2011), cited by 2
- K121579: EK Delivery Device (2012), cited by 1

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