# MEQ: System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 6
- Recalls: 9 (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)
- 2008: 14
- 2009: 10
- 2010: 7
- 2011: 6
- 2012: 4
- 2013: 2
- 2014: 4
- 2015: 2
- 2018: 1
- 2021: 1

## Most-cited predicates

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