Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magna Advanced Technologies, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
90 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991819 | MAGNATEK 30 | Magna Advanced Technologies, Inc. | 1999-08-19 | 84 | 0 |
| K982907 | MAGNATEK 40 | Magna Advanced Technologies, Inc. | 1998-10-02 | 45 | 0 |
| K983114 | MAGNATEK80 | Magna Advanced Technologies, Inc. | 1998-09-22 | 18 | 0 |
| K982846 | MTEK-1400 | Magna Advanced Technologies, Inc. | 1998-09-18 | 37 | 0 |
| K982405 | MTEK-1000 | Magna Advanced Technologies, Inc. | 1998-09-17 | 69 | 0 |
| K981310 | MAGNATEK C-300 | Magna Advanced Technologies, Inc. | 1998-07-09 | 90 | 0 |
| K981416 | MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 | Magna Advanced Technologies, Inc. | 1998-06-24 | 65 | 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