Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mega Electronics , Ltd. — 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) |
|---|---|---|---|---|---|
| K143032 | eMotion Faros ECG Mobile | Mega Electronics , Ltd. | 2015-03-29 | 158 | 0 |
| K131699 | EMOTION ECG MOBILE | Mega Electronics , Ltd. | 2013-11-26 | 168 | 0 |
| K993411 | FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL | Mega Electronics , Ltd. | 2000-01-10 | 90 | 0 |
| K963202 | MEGA ME 3000 PROFESSIONAL MUSCLE TESTER | Mega Electronics , Ltd. | 1997-05-19 | 277 | 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