# NAY: System, Surgical, Computer Controlled Instrument

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 166
- 510(k) review time 2021–2025: median 98 days (middle half 60–150)
- Recalls: 117 (2 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: 16
- 2018: 15
- 2019: 8
- 2020: 9
- 2021: 11
- 2022: 6
- 2023: 5
- 2024: 10
- 2025: 16
- 2026: 7

## Most-cited predicates
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories (2014), cited by 32
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), cited by 29
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System (2000), cited by 21
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000 (2005), cited by 20
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 (2009), cited by 20
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000 (2001), cited by 16
- K171294: da Vinci X Surgical System (2017), cited by 16
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System (2001), cited by 16
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000 (2002), cited by 15
- K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals (2012), cited by 15

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