Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Braincool AB — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232844 | The IQoolTM System | Braincool AB | 2023-10-04 | 20 | 0 |
| DEN210027 | The Cooral System | Braincool AB | 2022-10-14 | 469 | 0 |
| K180375 | The IQoolTM Warm System | Braincool AB | 2018-05-18 | 95 | 0 |
| K162523 | The IQool System | Braincool AB | 2017-05-03 | 236 | 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