Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mec Dynamics Corp — 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) |
|---|---|---|---|---|---|
| K121752 | AVIE TOTAL HB TEST SYSTEM | Mec Dynamics Corp | 2013-01-07 | 207 | 0 |
| K093548 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2011-07-20 | 610 | 0 |
| K091400 | MODIFICATION TO AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2009-06-11 | 30 | 0 |
| K081269 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2009-03-20 | 319 | 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