Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KZA — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
232 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152088 | IV-eye | Novarix Limited | 2016-02-24 | 212 | 0 |
| K101838 | VTS1000 | Vuetek Scientific, LLC | 2011-02-18 | 232 | 0 |
| K042679 | IR VIEWER | Infrared Imaging Systems, Inc. | 2004-12-10 | 72 | 0 |
| K982612 | ESP7 VENOUS IMAGE | Ironmaster, Inc. | 1998-12-14 | 140 | 0 |
| K780884 | HYPO-GRIP | Harco Products | 1978-08-10 | 72 | 0 |
| K780883 | E-Z-JECTOR | Harco Products | 1978-08-10 | 72 | 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