Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interventional Medical, Inc. · 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) |
|---|---|---|---|---|---|
| K880831 | LARGE LUMEN Y ADAPTER W/ROTATING DEVICE | Interventional Medical, Inc. | 1988-05-10 | 70 | 0 |
| K841071 | PRESSURE MANOMETER | Interventional Medical, Inc. | 1984-04-17 | 36 | 0 |
| K830609 | INFLATION DEVICE | Interventional Medical, Inc. | 1983-03-24 | 27 | 0 |
| K822243 | GUIDING CATHETER | Interventional Medical, Inc. | 1982-08-24 | 28 | 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