Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inrad, 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) |
|---|---|---|---|---|---|
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 | 132 | 0 |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | 2024-11-07 | 268 | 0 |
| K183503 | EasyMark Tissue Marker | Inrad, Inc. | 2019-10-17 | 304 | 0 |
| K112945 | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GA | Inrad, Inc. | 2011-11-03 | 30 | 1 |
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