# Thermi

- Location (FDA's records): Irving, TX
- FDA decisions: 2 (2016–2017): 2 510(k) clearances
- Product codes: GEI (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thermigen, Inc.: 1 (https://510kreport.com/company/thermigen)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Thermigen, Inc.: 1 (https://510kreport.com/company/thermigen)

## Its most-cited devices
- K161661: Thermi RF Accessories (2016), cited by 1
- K170116: Thermi Injectable RF Electrodes (2017), cited by 1

## Recent decisions
- K170116: Thermi Injectable RF Electrodes (Mar 13, 2017)
- K161661: Thermi RF Accessories (Aug 12, 2016)

Source page: https://510kreport.com/company/thermi