Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Izon Business Products, 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) |
|---|---|---|---|---|---|
| K010328 | MULTIPLE (IZON DNA BLOOD COLLECTION KIT) | Izon Business Products, Inc. | 2001-04-09 | 66 | 0 |
| K950257 | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-04-14 | 81 | 0 |
| K950221 | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 | 61 | 0 |
| K950246 | MULTIPLE (IZON URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 | 60 | 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