Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardeon Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
237 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042156 | CARDEON COBRA CATHETER | Cardeon Corp. | 2004-10-06 | 57 | 0 |
| K024058 | MODIFICATION TO CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-12-30 | 21 | 0 |
| K022042 | MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) | Cardeon Corp. | 2002-09-03 | 71 | 0 |
| K022174 | MODIFICATION TO CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-07-29 | 26 | 0 |
| K013593 | CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-06-24 | 237 | 0 |
| K001371 | CARDEON ASCENDING BALLOON CANNULA (ABC) | Cardeon Corp. | 2000-07-07 | 67 | 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