Tzora Active Systems , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tzora Active Systems , Ltd.” (first 2001, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 202 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 202 |
| 2016 | 0 | — |
| 2017 | 1 | 314 |
| 2018 | 1 | 266 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tzora Active Systems , Ltd. took a median 290 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 5 | 5 |
Review panels
Most recent Tzora Active Systems , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172409 | Lite | INI | 2018-05-02 | 266 |
| K160835 | Titan 3W | INI | 2017-02-02 | 314 |
| K150086 | Titan | INI | 2015-08-05 | 202 |
| K052204 | THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER | INI | 2006-02-15 | 187 |
| K012592 | EASYTRAVEL | INI | 2001-10-03 | 54 |
Recalls
openFDA lists no recalls under a recalling firm named Tzora Active Systems , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tzora Active Systems , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Tzora Active Systems , Ltd.” (first 2001, latest 2018), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tzora Active Systems , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tzora Active Systems , Ltd. is 202 days.
Which FDA product codes appear under Tzora Active Systems , Ltd.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 5).
Next steps
- See all 5 Tzora Active Systems , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Tzora Active Systems , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.