Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Levo AG — 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) |
|---|---|---|---|---|---|
| K140706 | LEVO MAX | Levo AG | 2015-01-21 | 306 | 0 |
| K083017 | LEVO C3 | Levo AG | 2008-10-24 | 15 | 0 |
| K051387 | LEVO COMFORT II | Levo AG | 2005-06-10 | 14 | 0 |
| K030893 | LEVO COMBI | Levo AG | 2003-04-02 | 12 | 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