Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio-Dynamics Laboratories, 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) |
|---|---|---|---|---|---|
| K781911 | ECG ANALYZER, HIGH SPEED | Cardio-Dynamics Laboratories, Inc. | 1978-11-30 | 16 | 0 |
| K781514 | ECG ELECTRODE, 2021, 2022, 2032, 2033 | Cardio-Dynamics Laboratories, Inc. | 1978-10-17 | 46 | 0 |
| K781152 | ELECTROCARDIOGRAPHIC ECG RECORDER | Cardio-Dynamics Laboratories, Inc. | 1978-08-31 | 52 | 0 |
| K770988 | FOAM ECG ELECTRODE, 2060 AND 2061 | Cardio-Dynamics Laboratories, Inc. | 1977-06-14 | 14 | 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