# Advanced Cooling Therapy, LLC

- Location (FDA's records): Chicago, IL
- FDA decisions: 3 (2015–2017): 2 510(k) clearances and 1 De Novo grant
- Product codes: PLA (3)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Attune Medical: 4 (https://510kreport.com/company/attune-medical)

## Its most-cited devices
- K170009: Esophageal Cooling Device (2017), cited by 2
- DEN140018: Esophageal Cooling Device (2015), cited by 2
- K152450: Esophageal Cooling Device (2016), cited by 2

## Recent decisions
- K170009: Esophageal Cooling Device (Mar 30, 2017)
- K152450: Esophageal Cooling Device (Jan 15, 2016)
- DEN140018: Esophageal Cooling Device (Jun 23, 2015)

Source page: https://510kreport.com/company/advanced-cooling-therapy