Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Voxar Limited — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043194 | VOXAR 3D PRODUCT FAMILY | Voxar Limited | 2005-01-11 | 54 | 0 |
| K020140 | VOXAR'S CALCIUM SCORING PRODUCT | Voxar Limited | 2002-01-28 | 12 | 0 |
| K012072 | VOXAR VC, MODEL 1.0 | Voxar Limited | 2001-07-12 | 10 | 0 |
| K992654 | PLUG 'N VIEW 3D, VERSION 1.0 | Voxar Limited | 1999-11-05 | 88 | 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