FDA applicant
Advanced Cooling Therapy, LLC
FDA records 3 decisions for Advanced Cooling Therapy, LLC (Chicago, IL) from 2015 to 2017: 2 510(k) clearances and 1 De Novo grant. All are in product code PLA (Esophageal Thermal Regulation And Gastric…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Advanced Cooling Therapy, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Advanced Cooling Therapy, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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