Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Medical Industries · 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) |
|---|---|---|---|---|---|
| K861276 | TAMPER PROOF CAP | Intl. Medical Industries | 1986-05-05 | 28 | 0 |
| K860434 | CHEMO-VENT | Intl. Medical Industries | 1986-02-12 | 8 | 0 |
| K850051 | VERSA-FILL 120 & FILL SET 42-50 | Intl. Medical Industries | 1985-03-06 | 57 | 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