Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Z-Kat, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030764 | Z-BOX | Z-Kat, Inc. | 2003-04-24 | 44 | 0 |
| K023975 | VOYAGER LINUX | Z-Kat, Inc. | 2002-12-20 | 18 | 0 |
| K013025 | MODIFICATION TO FLOUROLAB PLUS | Z-Kat, Inc. | 2001-10-03 | 23 | 0 |
| K002893 | FLUOROLAB PLUS | Z-Kat, Inc. | 2000-12-04 | 77 | 0 |
| K984298 | Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI | Z-Kat, Inc. | 1999-06-23 | 203 | 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