Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Tzora Active Systems , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
202 daysmedian FDA review time
314 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172409 | Lite | Tzora Active Systems , Ltd. | 2018-05-02 | 266 | 0 |
| K160835 | Titan 3W | Tzora Active Systems , Ltd. | 2017-02-02 | 314 | 0 |
| K150086 | Titan | Tzora Active Systems , Ltd. | 2015-08-05 | 202 | 0 |
| K052204 | THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER | Tzora Active Systems , Ltd. | 2006-02-15 | 187 | 0 |
| K012592 | EASYTRAVEL | Tzora Active Systems , Ltd. | 2001-10-03 | 54 | 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