Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
St. Jude Medical, Cardiac Rhythm Management Divisi · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
160 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 | 122 | 0 |
| K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-11 | 101 | 0 |
| K120298 | CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-08 | 98 | 0 |
| K111943 | AGILLS PF DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-09-29 | 83 | 0 |
| K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-01-19 | 77 | 0 |
| K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010-04-02 | 107 | 0 |
| K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, D | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-08-07 | 29 | 0 |
| K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-07-01 | 117 | 0 |
| K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-04-30 | 28 | 0 |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-03-13 | 160 | 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