Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Cardiorhythm · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
420 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981642 | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS | Medtronic Cardiorhythm | 1998-08-05 | 89 | 0 |
| K964272 | PERFORMR SERIES EP DIAGNOSTIC CATHETERS | Medtronic Cardiorhythm | 1997-01-23 | 90 | 0 |
| K953185 | PLATINUM SERIES EP DIAGNOSTIC CATHETERS | Medtronic Cardiorhythm | 1996-04-15 | 280 | 0 |
| K951347 | MARINR SERIES EP DIAGNOSTI CATHETERS | Medtronic Cardiorhythm | 1995-05-10 | 71 | 0 |
| K931794 | MARINR SERIES EP DIAGNOSTIC CATHETERS | Medtronic Cardiorhythm | 1994-06-06 | 420 | 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