Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Emergency Response Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
475 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | Medtronic Emergency Response Systems, Inc. | 2007-01-26 | 67 | 2 |
| K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR | Medtronic Emergency Response Systems, Inc. | 2006-12-22 | 71 | 5 |
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | Medtronic Emergency Response Systems, Inc. | 2006-02-17 | 203 | 3 |
| K052854 | LIFENET EXCHANGE SYSTEM | Medtronic Emergency Response Systems, Inc. | 2006-01-20 | 101 | 0 |
| K042404 | LIFEPAK, MODEL 1000 | Medtronic Emergency Response Systems, Inc. | 2005-12-22 | 475 | 2 |
| K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | Medtronic Emergency Response Systems, Inc. | 2004-07-01 | 29 | 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