Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiac Pathways Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
236 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER W | Cardiac Pathways Corp. | 2000-03-08 | 191 | 1 |
| K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAY | Cardiac Pathways Corp. | 1999-06-08 | 90 | 0 |
| K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 70 | Cardiac Pathways Corp. | 1999-01-27 | 190 | 0 |
| K983653 | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B | Cardiac Pathways Corp. | 1998-12-22 | 64 | 0 |
| K965066 | ARRHYTHMIA MAPPING SYSTEM (8100/8300) | Cardiac Pathways Corp. | 1997-08-11 | 236 | 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