Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FXN — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131596 | WOUND MEASURING & MONITORING DEVICE | Woundvision, LLC | 2013-12-11 | 191 | 0 |
| K130165 | PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 | Advanced Planimetric Services, LLC | 2013-08-30 | 219 | 0 |
| K070426 | SILHOUETTE, MODEL 1000.01 | Aranz Medical Limited | 2007-06-29 | 136 | 0 |
| K962148 | VERGE VIDEOMETER | Verg, Inc. | 1996-12-20 | 200 | 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