# Braincool AB

- Location (FDA's records): Lund, SE
- FDA decisions: 4 (2017–2023): 3 510(k) clearances and 1 De Novo grant
- Product codes: DWJ (2), QUA (1), NZE (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 3 (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
- Emcools Emergency Medical Cooling Systems AG: 1 (https://510kreport.com/company/emcools-emergency-medical-cooling-systems)
- Medivance, Inc.: 1 (https://510kreport.com/company/medivance)

## Firms that cite its devices most
- Zoll Circulation, Inc.: 1 (https://510kreport.com/company/zoll-circulation)
- Chemo Mouthpiece, LLC: 1 (https://510kreport.com/company/chemo-mouthpiece)

## Its most-cited devices
- DEN210027: The Cooral System (2022), cited by 1
- K162523: The IQool System (2017), cited by 1
- K180375: The IQoolTM Warm System (2018), cited by 1

## Recent decisions
- K232844: The IQoolTM System (Oct 4, 2023)
- DEN210027: The Cooral System (Oct 14, 2022)
- K180375: The IQoolTM Warm System (May 18, 2018)
- K162523: The IQool System (May 3, 2017)

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