Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FZO · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851788 | 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES, | Artiberia | 1985-06-20 | 56 | 0 |
| K834198 | JAKOBI SURG. INSTRUMENTS #12 40/41 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 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