# PQN: Carbon Dioxide Gas Controlled Tissue Expander

- Device class: 2; regulation: 21 CFR 878.3510; FDA's rule: 510(k) required
- FDA decisions: 3
- 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
- 2019: 1

## Most-cited predicates
- K170075: AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (2017), cited by 1
- DEN150055: AeroForm Tissue Expander System (2016), cited by 1

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