Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viztek, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
168 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160810 | ViZion DR + Wireless | Viztek, LLC | 2016-05-20 | 57 | 0 |
| K152279 | ViZion DR + Wireless | Viztek, LLC | 2015-09-10 | 29 | 0 |
| K142919 | EXA | Viztek, LLC | 2014-12-16 | 69 | 0 |
| K133139 | VIZION ULTRA | Viztek, LLC | 2014-04-03 | 168 | 0 |
| K123644 | VIZION + DR | Viztek, LLC | 2013-01-11 | 46 | 0 |
| K112661 | VIZION DR | Viztek, LLC | 2011-10-20 | 37 | 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