Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MLZ · 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) |
|---|---|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | 2022-05-04 | 119 | 0 |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, | Alcon Research, Ltd. | 2017-03-22 | 28 | 0 |
| K093305 | ENHANCED ULTRA VIT PROBE | Alcon Research, Ltd. | 2010-04-02 | 162 | 0 |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Advanced Medical Optics, Inc. | 2008-10-08 | 113 | 1 |
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