Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inter-Med 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) |
|---|---|---|---|---|---|
| K871291 | AM CATH ESWL STENT | Inter-Med Corp. | 1987-04-30 | 30 | 0 |
| K864669 | AM CATH ESWL STENT | Inter-Med Corp. | 1987-01-05 | 34 | 0 |
| K851922 | URETERAL STONE DISLODGER | Inter-Med Corp. | 1985-08-02 | 92 | 0 |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | Inter-Med Corp. | 1984-01-31 | 145 | 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