Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
I.Z.I. Medical Products Corp. · 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) |
|---|---|---|---|---|---|
| K990242 | TOPOGRAPHIC IMAGING MARKER | I.Z.I. Medical Products Corp. | 1999-03-03 | 37 | 0 |
| K990298 | TOPOGRAPHIC IMAGING MARKER | I.Z.I. Medical Products Corp. | 1999-03-03 | 30 | 0 |
| K964972 | SHADOWFORM | I.Z.I. Medical Products Corp. | 1997-05-05 | 144 | 0 |
| K962606 | TOPOGRAPHIC IMAGING MARKER | I.Z.I. Medical Products Corp. | 1996-08-07 | 36 | 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