Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Dex Intl. — 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) |
|---|---|---|---|---|---|
| K893569 | QUICK CHANGE MONTGOMERY STRAP | Med-Dex Intl. | 1989-09-25 | 139 | 0 |
| K884630 | MULTI-PURPOSE HOLDER | Med-Dex Intl. | 1988-11-22 | 15 | 0 |
| K881083 | GENERAL PURPOSE KIT | Med-Dex Intl. | 1988-04-07 | 24 | 0 |
| K881084 | UTILITY CLAMP | Med-Dex Intl. | 1988-03-25 | 11 | 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