Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio Search, Inc. · 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) |
|---|---|---|---|---|---|
| K842133 | EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS | Cardio Search, Inc. | 1985-02-19 | 265 | 0 |
| K841880 | ERYTHROCATH UMBILICAL CATHETER | Cardio Search, Inc. | 1985-01-14 | 252 | 0 |
| K833873 | CARDIOSEARCH RIGHT ATRIAL CATH- | Cardio Search, Inc. | 1984-06-11 | 216 | 0 |
| K832064 | VENOUS CATHETER | Cardio Search, Inc. | 1983-08-08 | 42 | 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