Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
St. Jude Medical, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
319 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018-04-23 | 258 | 0 |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | 2017-09-29 | 298 | 1 |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016-08-15 | 111 | 0 |
| K161102 | Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016-05-19 | 30 | 0 |
| K160716 | The Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016-04-14 | 30 | 0 |
| K140793 | NANOSTIM INTRODUCER KIT | St. Jude Medical, Inc. | 2014-12-17 | 261 | 0 |
| K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | St. Jude Medical, Inc. | 2014-05-28 | 196 | 0 |
| K131592 | ENLIGHTN RENAL GUIDE CATHETER | St. Jude Medical, Inc. | 2014-01-31 | 242 | 0 |
| K073700 | 6F PROXIS SYSTEM | St. Jude Medical, Inc. | 2008-10-02 | 276 | 0 |
| K042734 | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) | St. Jude Medical, Inc. | 2004-12-17 | 77 | 0 |
| K022363 | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) | St. Jude Medical, Inc. | 2002-09-19 | 59 | 0 |
| K014161 | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) | St. Jude Medical, Inc. | 2002-01-15 | 27 | 0 |
| K014037 | SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE | St. Jude Medical, Inc. | 2002-01-04 | 28 | 0 |
| K001367 | FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX | St. Jude Medical, Inc. | 2000-05-31 | 30 | 0 |
| K001346 | ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX | St. Jude Medical, Inc. | 2000-05-24 | 26 | 0 |
| K000119 | SJM TAILOR ANNULOPLASTY RING, MODEL TARN | St. Jude Medical, Inc. | 2000-02-17 | 30 | 0 |
| K961246 | SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M | St. Jude Medical, Inc. | 1997-02-14 | 319 | 0 |
| K935184 | REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WIT | St. Jude Medical, Inc. | 1995-02-10 | 472 | 0 |
| K933014 | LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI | St. Jude Medical, Inc. | 1994-09-28 | 464 | 0 |
| K921550 | LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP | St. Jude Medical, Inc. | 1992-05-21 | 58 | 0 |
| K902159 | BIFLEX(TM) ANNULOPLASTY RING | St. Jude Medical, Inc. | 1991-01-18 | 248 | 0 |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | 1990-03-19 | 52 | 0 |
| K894255 | ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP | St. Jude Medical, Inc. | 1989-09-26 | 98 | 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