Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Ireland · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
205 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | 2026-07-27 | 60 | 0 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | 2026-01-17 | 205 | 0 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 | 90 | 0 |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | 2025-06-11 | 89 | 0 |
| K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN C | Medtronic, Ireland | 2013-04-09 | 182 | 0 |
| K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BAL | Medtronic, Ireland | 2010-10-22 | 14 | 0 |
| K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM | Medtronic, Ireland | 2006-08-21 | 83 | 0 |
| K053431 | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM | Medtronic, Ireland | 2006-03-16 | 97 | 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