Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meddev International 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) |
|---|---|---|---|---|---|
| K940284 | MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION | Meddev International Corp. | 1994-02-28 | 55 | 0 |
| K931197 | MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT | Meddev International Corp. | 1993-09-23 | 198 | 0 |
| K874562 | SECURATRODE | Meddev International Corp. | 1988-01-28 | 85 | 0 |
| K771435 | URINARY LEG BAG, STEOILE | Meddev International Corp. | 1977-09-20 | 50 | 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