# PQM: Surgical Smoke Precipitator

- Device class: 2; regulation: 21 CFR 878.5050; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 180 days (middle half 158–183)
- 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)
- 2016: 1
- 2017: 1
- 2018: 1
- 2020: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- K200035: Ultravision Visual Field Clearing System (2020), cited by 3
- K231298: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (2023), cited by 1
- K170178: Ultravision Visual Field Clearing System (2017), cited by 1
- K182053: Ultravision™ Visual Field Clearing System (2018), cited by 1
- DEN150022: Ultravision Visual Clearing System (2016), cited by 1

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