Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Luneau Laboratories — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850068 | LUNE AU CURETTES | Luneau Laboratories | 1985-04-08 | 90 | 0 |
| K844364 | SKIASCOPIC RACKS | Luneau Laboratories | 1985-01-02 | 50 | 0 |
| K844365 | COLOR VISION TESTERS | Luneau Laboratories | 1985-01-02 | 50 | 0 |
| K844362 | OPHTHALMIC CHAIR | Luneau Laboratories | 1984-12-11 | 28 | 0 |
| K844363 | OPHTHALMIC STAND | Luneau Laboratories | 1984-12-05 | 22 | 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