Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KBG · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033591 | REPROCESSED TROCARS | Clearmedical, Inc. | 2005-06-03 | 568 | 0 |
| K013987 | REPROCESSED DISPOSABLE TROCARS | Adven Medical | 2002-03-01 | 87 | 0 |
| K844186 | CONTINENT STOMA SYSTEM & ACCESSORIES | Chesebrough-Pond'S U.S.A. Co. | 1985-01-15 | 78 | 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