Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lerner Laboratories, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
48 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | 1985-10-22 | 48 | 0 |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | 1985-10-22 | 15 | 0 |
| K821443 | FORMICAL | Lerner Laboratories, Inc. | 1982-06-02 | 19 | 0 |
| K761001 | PAP-TRAY II (CATALOG #C600-2) | Lerner Laboratories, Inc. | 1976-12-06 | 28 | 0 |
| K761000 | PAP-TRAY I (CATALOG #C600-1) | Lerner Laboratories, Inc. | 1976-12-06 | 28 | 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