Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardioline S.P.A — 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) |
|---|---|---|---|---|---|
| K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023-05-15 | 445 | 0 |
| K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016-11-02 | 229 | 0 |
| K160840 | ECG100+, ECG200+ | Cardioline S.P.A | 2016-08-12 | 137 | 0 |
| K150289 | CARDIOLINE HD+ | Cardioline S.P.A | 2015-08-27 | 203 | 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