Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magna-Lab, 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) |
|---|---|---|---|---|---|
| K020993 | ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) | Magna-Lab, Inc. | 2002-05-21 | 55 | 0 |
| K010802 | CARDIAC VIEW, MODEL 2001 | Magna Lab, Inc. | 2001-06-08 | 84 | 0 |
| K010513 | CARDIAC VIEW, MODEL 2001 | Magna-Lab, Inc. | 2001-05-21 | 89 | 0 |
| K940894 | MAGNA SL | Magna-Lab, Inc. | 1994-09-02 | 190 | 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