Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiotronics Systems, 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) |
|---|---|---|---|---|---|
| K971148 | 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1997-05-15 | 48 | 0 |
| K970719 | 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES | Cardiotronics Systems, Inc. | 1997-04-16 | 48 | 0 |
| K964991 | 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1997-01-15 | 33 | 0 |
| K964469 | 700-F SERIES STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1996-12-11 | 34 | 4 |
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