Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NFA — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
325 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073523 | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | Medtronic, Inc. | 2008-08-01 | 231 | 0 |
| K073563 | MODIFICATION TO PROXIS SYSTEM | St Jude Medical | 2008-01-31 | 43 | 0 |
| K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2007-01-19 | 29 | 0 |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -0 | Kensey Nash Corp. | 2006-10-20 | 25 | 0 |
| K060651 | PROXIS SYSTEM, MODEL EPS101 | St Jude Medical | 2006-09-13 | 184 | 0 |
| K052523 | PROXIS SYSTEM | Velocimed, Inc. | 2006-09-07 | 358 | 0 |
| K062201 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-08-11 | 10 | 0 |
| K061332 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | Boston Scientific Corp | 2006-08-11 | 91 | 0 |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | 2006-07-11 | 18 | 3 |
| K053195 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-06-23 | 220 | 0 |
| K051984 | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, | Boston Scientific Corp | 2006-04-10 | 262 | 0 |
| K052280 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | Boston Scientific Corp | 2005-11-07 | 77 | 0 |
| K051179 | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | Boston Scientific Corp | 2005-06-08 | 30 | 0 |
| K042040 | TRIACTIV SYSTEM | Kensey Nash Corp. | 2005-03-23 | 237 | 3 |
| K032884 | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RET | Boston Scientific Epi | 2004-08-06 | 325 | 0 |
| K023691 | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | Boston Scientific Epi | 2003-06-04 | 215 | 0 |
| K030201 | MODIFICATION TO EXPORT ASPIRATION CATHETER | Medtronic Vascular | 2003-03-26 | 64 | 0 |
| K023878 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Vascular | 2003-01-24 | 64 | 0 |
| K013913 | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION | Medtronic Percusurge, Inc. | 2002-11-15 | 353 | 0 |
| K023303 | EXPORT ASPIRATION CATHETER | Medtronic Vascular | 2002-10-29 | 26 | 0 |
| K014223 | MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRAT | Medtronic Percusurge, Inc. | 2002-01-25 | 30 | 0 |
| K003992 | PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYST | Percu Surge, Inc. | 2001-06-01 | 157 | 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