# PNV: Impedance Measuring Device Utilizing Oscillation Techniques

- Device class: 2; regulation: 21 CFR 868.1840; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 440 days (middle half 440–440)
- 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
- 2020: 1
- 2023: 1

## Most-cited predicates
- K152585: Resmon PRO FULL (2016), cited by 1
- K170185: tremoFlo C-100 Airwave Oscillometry System (2017), cited by 1

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