# QAF: Impedance Plethysmograph, Cranial

- Device class: 2; regulation: 21 CFR 870.2770; 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)
- 2017: 1
- 2018: 1
- 2026: 1

## Most-cited predicates
- K182967: Visor System (2018), cited by 1
- K171186: Cerebrotech CMS-5000 (2017), cited by 1

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