Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Andover Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
145 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910494 | RESTING EKG ELECTRODE SERIES | Medtronic Andover Medical, Inc. | 1991-04-22 | 76 | 0 |
| K905446 | MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE | Medtronic Andover Medical, Inc. | 1991-02-05 | 62 | 1 |
| K903018 | MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 | Medtronic Andover Medical, Inc. | 1990-12-03 | 145 | 0 |
| K903554 | NORTECH MODEL 87202204 ELECTRODE | Medtronic Andover Medical, Inc. | 1990-08-30 | 23 | 0 |
| K882174 | MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE | Medtronic Andover Medical, Inc. | 1988-07-22 | 65 | 0 |
| K852469 | SAF-D-FIB | Medtronic Andover Medical, Inc. | 1985-09-16 | 95 | 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