# FYD: Apparatus, Exhaust, Surgical

- Device class: 2; regulation: 21 CFR 878.5070; FDA's rule: 510(k) required
- FDA decisions: 75
- 510(k) review time 2021–2025: median 155 days (middle half 126–182)
- Recalls: 7 (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)
- 2009: 1
- 2014: 1
- 2015: 1
- 2017: 1
- 2018: 1
- 2019: 3
- 2020: 1
- 2021: 1
- 2022: 1
- 2024: 2

## Most-cited predicates
- K052797: Lapevac, Filtration Device for the Periotoneum (2006), cited by 4
- K012991: Neptune Waste Management Ststem (2001), cited by 4
- K924732: Porta Plumesafe (TM) 601 Smoke Evacuation System (1993), cited by 4
- K131402: Visiclear Smoke Evacuation System (2014), cited by 4
- K874512: Modified Biovac:Lfa Laser Fume Evacuation System (1988), cited by 2
- K932230: Crystal Vision and Accessories (1994), cited by 2
- K000904: Penadapt 10 (2000), cited by 2
- K980915: Valleylab Optimumm Smoke Evacuator System (1998), cited by 2
- K911154: Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200 (1991), cited by 2
- K992361: Pall Surgiclear Laparoscopic Smoke Filtration System, Model CLSF1 (1999), cited by 2

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