Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Izi Medical Products, LLC · 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) |
|---|---|---|---|---|---|
| K191012 | Navigated Pedicle Access Kit | Izi Medical Products, LLC | 2019-08-07 | 113 | 0 |
| K162265 | CushionCast Moldable Cushions | Izi Medical Products, LLC | 2016-11-15 | 96 | 0 |
| K143241 | MDT Navigable Brain Biopsy Cannula | Izi Medical Products, LLC | 2015-04-13 | 152 | 0 |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation Sy | Izi Medical Products, LLC | 2015-03-20 | 210 | 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