Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZB — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914226 | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1991-11-19 | 60 | 0 |
| K870756 | VEIN GRAFT EAR SCISSORS | Treace Medical, Inc. | 1987-03-03 | 5 | 0 |
| K833603 | SCISSORS SHEA BELLUCC | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K822196 | EAR SCISSORS | Kelleher Corp. | 1982-08-30 | 38 | 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