Z-Kat, Inc.: FDA clearances and approvals
Z-Kat, Inc. has 5 FDA 510(k) clearances (first 1999, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time: 44 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 5 | 5 |
Review panels
- Neurology (5)
Most recent Z-Kat, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030764 | Z-BOX | HAW | 2003-04-24 | 44 |
| K023975 | VOYAGER LINUX | HAW | 2002-12-20 | 18 |
| K013025 | MODIFICATION TO FLOUROLAB PLUS | HAW | 2001-10-03 | 23 |
| K002893 | FLUOROLAB PLUS | HAW | 2000-12-04 | 77 |
| K984298 | Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI | HAW | 1999-06-23 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Z-Kat, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Z-Kat, Inc. have?
Z-Kat, Inc. has 5 FDA 510(k) clearances (first 1999, latest 2003), across 1 product code in 1 review panel.
How long does FDA take to clear Z-Kat, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Z-Kat, Inc.'s cleared 510(k)s is 44 days.
What devices does Z-Kat, Inc. make?
Its most frequent FDA product codes are HAW (Neurological Stereotaxic Instrument, 5).
Has Z-Kat, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Z-Kat, Inc. Related entities may recall under other names.
Next steps
- See all 5 Z-Kat, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Z-Kat, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.