Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Metronic, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | Metronic, Inc. | 2003-05-16 | 29 | 0 |
| K911827 | MODEL 5866-9M & MODEL 6981M | Metronic, Inc. | 1991-07-23 | 90 | 0 |
| K874884 | MEDTRONIC(R) ORTHOFLEX(TM) | Metronic, Inc. | 1988-01-28 | 58 | 0 |
| K832505 | IMAGE PROCESSING SYS A3 | Metronic, Inc. | 1983-09-12 | 47 | 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