Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LEZ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091682 | LSVT C OR LSVT COMPANION, MODEL V.1 | Lsvt Global, LLC | 2009-08-20 | 71 | 0 |
| K982396 | VISIVOX, MODEL V-2 | Rsq, LLC | 1998-09-14 | 67 | 0 |
| K802870 | RION ELECTRO-PALATOGRAPH MODEL DP-01 | Kindel & Anderson | 1980-12-17 | 33 | 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