Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mecta Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965070 | SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | Mecta Corp. | 1997-03-06 | 85 | 0 |
| K960754 | SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | Mecta Corp. | 1996-09-18 | 208 | 0 |
| K852069 | MECTA ECT DEVICE MODELS SR & JR | Mecta Corp. | 1985-08-09 | 91 | 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