Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Cooling Therapy, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170009 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2017-03-30 | 86 | 0 |
| K152450 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2016-01-15 | 140 | 0 |
| DEN140018 | ESOPHAGEAL COOLING DEVICE | Advanced Cooling Therapy, LLC | 2015-06-23 | 410 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda