Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Electronic Assn. — 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) |
|---|---|---|---|---|---|
| K913800 | MEDA CROWN SERIES | Medical Electronic Assn. | 1991-10-04 | 44 | 0 |
| K882943 | MEDA ONE-STEP | Medical Electronic Assn. | 1988-08-19 | 39 | 0 |
| K862011 | MULTI-DAY ELECTRODES | Medical Electronic Assn. | 1986-07-03 | 36 | 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