Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorenz Biotech S.P.A. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080902 | FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FRE | Lorenz Biotech S.P.A. | 2008-06-13 | 72 | 0 |
| K061828 | LORENZ BIOTECH APTIVA, VERSION 2.13 | Lorenz Biotech S.P.A. | 2007-08-24 | 422 | 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