Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiodyne, 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) |
|---|---|---|---|---|---|
| K911871 | CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS | Cardiodyne, Inc. | 1991-11-07 | 195 | 0 |
| K781932 | BLOOD PRESSURE RECORDER | Cardiodyne, Inc. | 1978-11-29 | 9 | 0 |
| K772027 | CARDIOCASSETTE II | Cardiodyne, Inc. | 1977-11-09 | 13 | 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