# Thermasolutions, LLC

- Location (FDA's records): White Bear Lake, MN
- FDA decisions: 3 (2013–2025): 3 510(k) clearances
- Names in FDA's records: Thermasolutions, LLC (2); Thermasolutions, Inc. (1)
- Product codes: MLW (2), GCJ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 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
- Dannik: 1 (https://510kreport.com/company/dannik)
- Hemocleanse, Inc.: 1 (https://510kreport.com/company/hemocleanse)

## Firms that cite its devices most
- Reger Medizintechnik, GmbH: 1 (https://510kreport.com/company/reger-medizintechnik)

## Its most-cited devices
- K222575: HurriChem Device Kit (2022), cited by 1

## Recent decisions
- K240447: ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (May 5, 2025)
- K222575: HurriChem Device Kit (Dec 6, 2022)
- K131583: Thermochem HT-2000 (Oct 3, 2013)

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