# NKX: Needle, Phacoemulsification, Reprocessed

- Device class: 2; regulation: 21 CFR 886.4670; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 10 (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)
- 2001: 2
- 2003: 1
- 2005: 1
- 2007: 1

## Most-cited predicates
- K030179: Medisiss Phacoemulsification Tips/Needles (2003), cited by 1

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