Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cardio Medical Products, Inc. · 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) |
|---|---|---|---|---|---|
| K103651 | CARDIOMED | Cardio Medical Products, Inc. | 2011-10-04 | 294 | 0 |
| K103334 | CARDIO MED | Cardio Medical Products, Inc. | 2011-01-18 | 64 | 0 |
| K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | Cardio Medical Products, Inc. | 2011-01-11 | 77 | 1 |
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