# NEY: System, Ablation, Microwave And Accessories

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 68
- 510(k) review time 2021–2025: median 139 days (middle half 108–251)
- Recalls: 17 (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)
- 2017: 3
- 2018: 3
- 2019: 2
- 2020: 7
- 2021: 4
- 2022: 1
- 2023: 9
- 2024: 7
- 2025: 1
- 2026: 2

## Most-cited predicates
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007 (2001), cited by 12
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System (2002), cited by 9
- K011676: Vivawave Microwave System (2002), cited by 9
- K133821: Emprint Ablation System (2014), cited by 8
- K163105: Emprint Ablation System (2016), cited by 6
- K053535: Vivawave Microwave Ablation System (2006), cited by 6
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), cited by 6
- K113237: Certus 140 2.45GHZ Ablation System (2012), cited by 5
- K072687: Valleylab Microwave Ablation Generator (2008), cited by 4
- K122217: Certus 140 2.45GHZ Ablation System (2012), cited by 4

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